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NAMSA

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June 2016

Sae Reporting Requirements In Germany And Austria

June 20, 2016 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

SAE reporting is always a very critical part of a Clinical Trial, and within the EU, differences between requirements by national Law between the EU Member States also appear. Andrea Offer, Medical Research Manager at NAMSA GmbH, Germany will speak about Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria during this webinar presented by NAMSA

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NAMSA Webinar: FDA Biological Evaluation Guidance

June 21, 2016 @ 2:30 pm - 3:30 pm
Webinar Online Event, OH United States

On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff.” This guidance document discusses the following topics: Use of risk assessments for biocompatibility evaluations for a proposed medical device Use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints…

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July 2016

Ensuring A Successful Collaboration Between Sponsors & CROs

July 27, 2016 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

For many medical device and pharmaceutical companies, outsourcing some or all aspects of their clinical study support is becoming more common. After years of product development, the clinical study is the last step in getting the product to the market and/or the most expensive phase of the product development life cycle. Choosing a CRO partner for your clinical study could make your clinical research work a resounding success, if done correctly, or a colossal failure, if not done well. From…

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August 2016

IDE Submissions – Navigating an Efficient Path to Full Approval

August 9, 2016 @ 2:00 pm - 3:30 pm
Webinar Online Event, OH United States

Obtaining full FDA approval of an Investigational Device Exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device. During this webinar, presented by NAMSA, the FDA will share their perspectives on the pitfalls and opportunities associated with preparing an IDE submission and interacting with FDA before, during, and after the submission. The goal is to convey important observations and recommendations that will help you to understand how…

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Risk-Based Monitoring in Clinical Trials: A Cross-Functional Approach

August 17, 2016 @ 10:00 am - 11:00 pm
Webinar Online Event, OH United States

Risk-based monitoring (RBM) extends beyond the idea of simply reducing onsite monitoring by performing less than 100% source document verification. Rather, a comprehensive implementation of RBM can provide an adaptable, integrated approach to monitoring that focuses on identifying and addressing risks to patient safety and data quality. In this process, a risk assessment discussion takes place at the planning stage and options for tailoring monitoring methods and resources to address those risks.  During the initial stage of this webinar, presented by NAMSA,…

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NAMSA Webinar: New FDA Guidance on Biological Evaluation Panel Discussion

August 31, 2016 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

On June 16, 2016 the FDA officially released the much-anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff. In response to the guidance release, NAMSA conducted an informational webinar on June 21st providing medical device manufacturers the first in-depth and interactive overview into this guidance. We highlighted important changes critical for manufacturers to know…

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September 2016

NAMSA Training Series Boston – Biological Safety

September 12, 2016 - September 15, 2016
Hotel Commonwealth, 500 Commonwealth Avenue
Boston, MA 02215 United States
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This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants must attend and complete all exercises to be certified as a biological safety specialist.…

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January 2017

MRO Summit presented by NAMSA

January 18, 2017 @ 9:00 am - 4:00 pm
DoubleTree Columbus – Worthington, 175 Hutchinson Ave
Columbus, OH 43235 United States
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NAMSA’s MRO Summit program brings thought leadership and industry professionals to you. These complimentary, intimate gatherings allow for expert discussions and shared experiences in medical device development. Within a few hours’ time, you will hear presentations, panel conversations and experiential learning, and will be a part of a day devoted to the art of efficient medical device development. Ultimately, you will leave the summit with recommendations, updates, guidance and resources critical to your device development process, as well as tools to help you…

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NAMSA GCIC Grand Opening Event

January 19, 2017 @ 11:00 am - 3:30 pm
Global Cardiovascular Innovations Center (GCIC), 10000 Cedar Avenue
Cleveland, OH 44195 United States
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NAMSA invites you to attend a special session on leading-edge strategies and best practices to help you successfully navigate your path to successful submission. Agenda: 11:00 a.m. – 11:30 a.m. – Registration & Networking 11:30 a.m. – 12:30 p.m. – Lunch with Presentation and Q&A Learn how NAMSA’s MRO services can accelerate your medical device product through the development life cycle. Time will be allotted to answer questions pertaining to NAMSA’s testing, clinical and consulting capabilities. 12:30 p.m. – 3:30…

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March 2017

Webinar: Designing an Effective Clinical Trial for FDA Submission

March 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for its latest webinar on "Designing an Effective Clinical Trial for FDA Submission," in which they will discuss various aspects of designing and conducting clinical trials that lead to successful submissions to the Food & Drug Administration (FDA), including best practices for getting the most out of your communication with the FDA. The information provided during this webinar will be based on the experience of Richard Kotz, NAMSA's Senior Medical Research Scientist for Biostatistics, and former Statistical Reviewer…

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Webinar: Bioskills and Its Role in Product Development

March 29, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Bioskills is an essential part of any medical device development program for the testing and verification of the intended use and performance of a medical device, IVD or regenerative medicine product. It also serves as a critical step for device manufacturers and health care professionals to facilitate cross-functional interaction and learning that leads to the efficient development of new and innovative medical technologies. Join NAMSA for its upcoming webinar, “Bioskills and Its Role in Product Development,” and learn how the use…

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April 2017

Webinar: The Benefits of Utilizing a Contract FCE in Clinical Trials

April 11, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join NAMSA for a joint webinar with MassMedic where we will discuss how medical device organizations can utilize contract Field Clinical Engineers (FCEs) to achieve efficiencies throughout the various stages of a clinical trial. Attendees can expect to better understand how FCEs can function as key team members through on-site clinical and technical support, and provide continuous oversight, education, protocol review and clarification for sponsors. This webinar will be presented by NAMSA's Paul Budny, RN, CCRA, CCRP; Field Clinical Engineer.

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May 2017

Webinar: The Purpose & Value of Chemical Characterization & Biological Risk Assessment in Medical Device Development

May 23, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Medical device organizations that manufacture products that involve patient contact are almost always required to perform biological safety evaluations, per ISO 10993-1, to ensure end-user safety. On June 16, 2016, the U.S. Food & Drug Administration (FDA) further expanded – and clarified – how device manufacturers seeking U.S. market clearance should comply with this standard as it relates to the evaluation and testing of devices throughout the risk management process. Using a risk-based approach, the FDA guidance includes detailed recommendations…

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Webinar: The EU IVD Regulation- Top 5 Changes for Medical Device Manufacturers to Consider

May 25, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The current EU IVD Directive (98/79/EC) has existed in Europe since 1998. However, as a result of continued scientific and technological advancements, this Directive is no longer 'fit for purpose.' Over time, there have been significant deviations from the Directive, forcing a departure from the document's original objectives and goals of maintaining the health and safety of IVD devices. The new In vitro Diagnostic Regulation (IVDR) was officially passed by the EU Parliament on April 4, 2017, which includes changes…

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June 2017

Webinar – Clinical Studies in China: Understanding the Regulatory Framework & Trial Process

June 7, 2017 @ 10:00 am - 11:00 pm
Webinar Online Event, OH United States

Prior to 2014, medical device manufacturers wishing to introduce products to the Chinese marketplace were able to do so only if a subsequent approval was granted by the United States Food & Drug Administration (FDA) or the European Medicines Agency (EMA), per China Food & Drug Administration (CFDA) regulations. However, beginning in October of 2014, this approval process shifted significantly to require device manufacturers to conduct local clinical trials to demonstrate product efficacy and safety if no sufficient or existing data…

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Webinar: Clinical Trials in China- A Regulatory Framework and the Clinical Trial Process

June 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Please join us on June 7th at 10:00 AM EDT for latest webinar! Prior to 2014, medical device manufacturers wishing to introduce products to the Chinese marketplace were able to do so if a subsequent approval was granted by the United States Food & Drug Administration (FDA) or the European Medicines Agency (EMA), per China Food & Drug Administration (CFDA) regulations. However, beginning in October of 2014, this approval process shifted significantly requiring product manufacturers to conduct local clinical trials…

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July 2017

Webinar: The Value of Preclinical Studies from Concept to Commercialization

July 13, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA on July 13 for this upcoming webinar. It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support. Join us for our upcoming webinar as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical…

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Webinar: Understanding the FDA/CMS Parallel Review Process

July 18, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

NAMSA is excited to present a special joint webinar with the Medical Alley Association (MAA). Learn direct from medical device industry experts, Ken Skodacek (Policy Analyst), FDA Center for Devices and Radiological Health; and Seth Goldenberg (Director of Product Development Strategy), NAMSA, as they discuss the FDA/CMS Parallel Review Process. There are numerous stakeholders that must be considered when bringing a medical device to market. These include regulatory agencies, healthcare payers, healthcare providers, patients, and healthcare technology assessment organizations, just…

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Webinar: Understanding Medical Device Regulatory Pathways in China and Japan

July 20, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The Countries of China and Japan each present their own unique set of challenges pertaining to medical device development. This is especially true for foreign manufacturers as they strive to stay abreast of the quickly changing device regulations and product approval processes in these sometimes tough-to-navigate geographies. Join NAMSA for a webinar with XTalks on July 20, 2017, as NAMSA regulatory experts Lei Yang, Medical Research Manager (China); and Kei Yoshikawa, Medical Research Manager (Japan), present information that will assist…

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August 2017

NAMSA Webinar: ISO 13485:2016 – Ensuring a Smooth Transition Through Effective Preparation

August 31, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

In 2016, significant revisions were made to the quality management standard ISO 13485, an internationally recognized standard for all medical product manufacturers. The updated changes to ISO 13485 – the first since 2003 – demonstrate the increasing Quality System requirements for the global medical device industry and how organizations must adhere to the forthcoming and revised standard. Join NAMSA’s regulatory expert, Linda Mummah Schendel, Principal Medical Research Manager, as we discuss the steps that medical device manufacturers should take now…

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September 2017

NAMSA Webinar: The Value of Preclinical Studies from Concept to Commercialization – September

September 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for this webinar on September 7. It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support. Join us for our upcoming webinar as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical Strategy-NAMSA) will…

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Biocompatibility of Medical Devices Two Day Certification Course

September 25, 2017 - September 26, 2017
Sheraton Philadelphia Downtown, 201 N 17th St
Philadelphia, PA 19103 United States
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Practice how to execute your plan from development to completion, and how to schedule and document the implementation of your biocompatibility plan in this certification course presented by NAMSA Understand and apply ISO 10993-1 and the FDA Guidance on its use. Discover how to use Materials Characterization and how it applies to biological safety. Learn about ISO 14971 and how – in combination with ISO 10993-1 – it can be used as a tool for hazard identification. Learn how to…

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October 2017

Webinar: ISO 13485:2016: How to Incorporate Risk-Based Quality Systems That Lead to Efficient Decision Making

October 19, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The use of risk management per International Organization for Standardization (ISO) 14971 has been long-established and is typically well understood within the medical device development industry. However, with forthcoming updates to ISO 13485:2016 just on the horizon, there will be an even greater importance placed on utilizing risk-based decision making and planning for quality system elements unrelated to design controls. These changes will require further learning and understanding by medical device manufacturers well in advance of the mandatory compliance date…

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NAMSA Webinar: ISO 13485:2016: How to Incorporate Risk-Based Quality Systems That Lead to Efficient Decision Making

October 19, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on October 19, 2017 at 10AM. The use of risk management per International Organization for Standardization (ISO) 14971 has been long-established and is typically well understood within the medical device development industry. However, with forthcoming updates to ISO 13485:2016 just on the horizon, there will be an even greater importance placed on utilizing risk-based decision making and planning for quality system elements unrelated to design controls. These changes will require further learning and…

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November 2017

NAMSA Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices

November 29, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on November 29 from 12 pm - 1 pm. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the recent requirements of ISO 10993-1: Biological evaluation…

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December 2017

Webinar: U.S. FDA Advisory Panel Meetings, Strategies to Maximize Success, presented by NAMSA

December 7, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

To better understand how to effectively prepare and plan for successful Advisory Panel meetings, NAMSA is partnering with X-Talks to present the webinar, “U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success”

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February 2018

NAMSA Webinar: How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

February 21, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on February 21 from 1-2 PM. Often, real-world data (RWD) routinely collected during patient treatment and management provides tangible information pertaining to the experiences of medical device end-users. These data sources range from medical device registries, electronic health records (EHRs), claims and billing data, patient-generated information, and even data gathered from mobile devices. Under the right conditions, information derived from these sources can be utilized to support various medical device regulatory pathways and…

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March 2018

NAMSA Webinar: Leveraging Post-Market Data to Support EU MDR Compliance

March 28, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for Leveraging Post-Market Data to Support EU MDR Compliance on March 28 at 10AM. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities have historically been a critical part of conformity with the Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD). However, over the last year, there has been an increased emphasis on PMS and PMCF compliance initiatives under the new EU Medical Device Regulation 2017/745 (MDR). The amplified focus on…

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April 2018

NAMSA Webinar: Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1

April 11, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on April 11 for the webinar Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the…

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June 2018

Webinar: The Design and Development of Preclinical Studies

June 28, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for the webinar The Design and Development of Preclinical Studies on June 28 at 10AM. Within the medical device development industry, preclinical studies are on the rise as medical technologies become progressively complex. While biocompatibility testing is required for novel devices, biological effects can increasingly be addressed by pairing materials characterization with risk assessment activities. However, the assessment of critical preclinical endpoints are often only achievable through the utilization of in vivo studies, and preclinical studies are typically required to address…

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July 2018

Webinar: Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

July 12, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Medical device organizations that manufacture products that involve patient contact are almost always required to perform some level chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential…

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Webinar: How to Effectively Navigate Radiation Sterilization Validation Scenarios

July 26, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Radiation sterilization has new and updated methods for conducting terminal sterilization validations on devices intended to be exposed to either gamma or electron beam irradiation processes. For example, flexibility of the minimum terminal sterilization dose can now be determined based on a product’s microbial population (bioburden). NAMSA invites you to join us on July 26, 2018 (10-11 AM ET) as Ed Arscott, Senior Product Development Strategist, discusses the following: Testing approaches for radiation sterilization validation, including New and modified methods…

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August 2018

Webinar: EU MDR 2017/745: Optimizing Clinical Evaluation Reports Within the Medical Device Lifecycle

August 7, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

As there are less than two years remaining prior to the MDR enforcement, it is critical that EU device manufacturers prepare now for conformity by May 2020. In this webinar, NAMSA’s Manager of Medical Writing and Regulatory Services (EMEA), will examine the requirements listed in the MDR and MEDDEV 2.7/1 Rev 4, and discuss why device manufacturers shall not consider the CER a mandatory document for NBs or authorities, but rather as a crucial tool for a smooth transition for MDR and beyond.…

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Webinar: The New ISO 10993-1:2018 – What Now?

August 27, 2018 @ 10:30 am - 11:30 am
Webinar Online Event, OH United States

This webinar, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements. Questions to be addressed include: What are the changes to the General Principles Applying to Biological Evaluation of Medical Devices? Is there clarification on when chemical characterization testing may or may not be needed? What are the categorization changes and how does that…

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October 2018

NAMSA Webinar: EU MDR – General Safety & Performance Requirements for the Biocompatibility of Medical Devices

October 23, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar EU MDR - General Safety & Performance Requirements for the Biocompatibility of Medical Devices. Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current…

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November 2018

IVD Clinical Trials – Essential Components for Product Launch in 2019 & Beyond

November 6, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on 11/6 at 10am. Webinar Description: As in vitro diagnostic (IVD) markets and regulations change, it’s imperative to stay up-to-date on clinical trial components that are required to facilitate efficient, cost-effective market approvals. During this NAMSA-sponsored webinar, Kristin Jones, MS, CCRA (Principal Medical Research Manager), will discuss the essential mechanisms that must be addressed throughout IVD clinical studies regardless of product type or intended market launch territory. Highlighted will be: An overview of…

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January 2019

NAMSA Webinar: Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers

January 17 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA For the webinar Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers on January 17 at 10AM. Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning. This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact…

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February 2019

NAMSA Webinar: Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization

February 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States + Google Map

Join BioOhio member NAMSA for the webinar Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization on February 20 at 11am EST. Most medical technology entrepreneurs will tell you that in recent years, reimbursement has become as large of a barrier to successful commercialization as regulatory clearance. Medical device manufacturers that do not plan early for reimbursement risk prolonged delays in bringing products to the market as the FDA approval/clearance process is an extremely important, single, sentinel event. In order to maximize…

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March 2019

NAMSA Webinar: Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary

March 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on Design Control: Understanding the Benefits of Starting Early and Why it's Necessary on March 20 at 11 am. While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a…

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April 2019

NAMSA Webinar: Use of OUS Clinical Data in Medical Device Product Development

April 17 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on the Use of OUS Clinical Data in Medical Device Product Development on April 17 at 11 am. In February 2018, the U.S. Food & Drug Administration (FDA) issued a final rule on an updated regulation pertaining to the acceptance of data from clinical investigations conducted outside the United States (OUS) to support IDEs or submissions (i.e., PMAs). While it is common for medical device manufacturers to utilize OUS clinically applicable data (including clinical…

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NAMSA Webinar: How to Select the Right EU Notified Body for IVDR Compliance

April 30 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on How to Select the Right EU Notified Body for IVDR Compliance on April 30 at 10am EST. The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746). Topics to be covered during this webinar include: The role of an EU Notified Body overseeing the IVD Regulation (2017/746); Current challenges Notified Bodies are facing…

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June 2019

NAMSA Webinar: How to Implement an Effective Internal Audit Program

June 19 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on June 19 from 11am - 12pm EST for the webinar How to Implement an Effective Internal Audit Program. An organization’s internal audit program is more than meeting the requirements of the 21 CFR 820, ISO 13485 or ISO 9001 standards. An effective internal audit program is an essential part of an effective Quality Management System (QMS), and can be a key communication tool in the promotion of continual improvement throughout the organization, as well as provide insight in areas of…

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