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Regulatory and Quality Solutions

(877) 652-0830|http://www.rqteam.com/

September 2014

Medical Device Development Lifecycle: A Discussion with the Experts

September 11, 2014 @ 8:00 am - 11:30 am
JumpStart, 6701 Carnegie Ave., #100
Cleveland, OH 44103 United States
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Do you have a medical device idea and want to make sure no one steals it? Do you have a product and are stuck somewhere between clinical trials and clearance? Do you have clearance and customers, but aren't sure you're going to get paid? Our start-to-finish product group of experts can help! Experts from Regulatory and Quality Solutions, Viscus Biologics, Nottingham Spirk, IMARC Research, SS&G Heathcare and DG Medical will answer these questions and be available following the session for confidential discussions. So,…

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February 2017

A Risk-Based Approach to Your QMS Implementation Webinar

February 28, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Please join R&Q for a free Intelligence Series webinar: A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015. This webinar presented by Regulatory and Quality Solutions outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. In this session, R&Q will establish a basic understanding of the application of the risk-based approach in your QMS process, the evidence…

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March 2017

R&Q Intelligence Series: Medical Device Single Audit Program (MDSAP)

March 28, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Attend this webinar, presented by Regulatory and Quality Solutions, if you want to understand MDSAP inside and out and be sufficiently prepared for its implementation Having been on the receiving end of two MDSAP audits, special R&Q Intelligence Series guest Connie Hoy of Cynosure Inc. (recently acquired by Hologic) will describe her successful first-hand experiences and offer step-by-step practical advice on how to adequately prepare for MDSAP and be successful. Her recent real-world case studies provide the perfect examples of…

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April 2017

Webinar: EU MDR- Assessing the impact and next steps.

April 25, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join the next R&Q Intelligence Series webinar: EU MDR: Assessing the impact and next steps. The presentation slides and webinar recording will be made available to all registrants. Know the essential EU MDR requirements. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’…

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May 2017

R&Q Intelligence Series Webinar

May 23, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7.1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well, once the regulation comes into force. It is important to be proactive to ensure CERs will meet your…

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July 2017

Webinar: Cybersecurity for Medical Devices

July 25, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Register for July's R&Q Intelligence Series webinar. The free session will be held on Tuesday, July 25 from 1:00pm - 2:00pm EST, and the presentation slides and webinar recording will be made available to all registrants. The emphasis on security is here. And here to stay. The regulations at the federal level mandate that healthcare organizations, financial institutions, and federal agencies should protect their systems, the information they collect, and consider the risks to their user population. This webinar will outline…

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August 2017

R&Q Webinar: Risk-Based Approach to ISO 13485:2016

August 22, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. The concepts of risk management are not new. In previous editions of ISO 13485, risk management primarily focused on product risk using design risk. ISO 13485:2016 places greater…

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September 2017

R&Q Webinar: EU MDR / CER Portfolio Planning

September 26, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio Leadership Member R&Q for this free webinar on September 26 at 1PM. Know the essential EU MDR Portfolio planning requirements. Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.…

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November 2017

Webinar: Preparing Your CER For MDR

November 28, 2017 @ 8:00 am - 5:00 pm
Webinar Online Event, OH United States

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is now. The Clinical Evaluation Report (CER) is required under the…

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January 2018

Webinar: QMS for EU MDR

January 23, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

New EU regulations for medical devices come into full application by May 2020. The parallel regulations for IVDs apply from 2022. This particularly affects those organizations that may have not been previously been subject to regulation (e.g., distributors, importers) and those for whom the regulatory requirements have increased (manufacturers, authorized representatives). Medical device organizations must have an adequate quality management system in place to maintain access to the EU market and other markets that recognize EU authorizations. They need to…

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February 2018

R&Q Intelligence Series Webinar: Technical Documentation for EU MDR

February 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

This webinar will provide the background and requirements that medical device manufacturers will need for their technical documentation to meet the requirements of the European Medical Device Regulations (EU MDR). This is designed to set the foundation for your planning of next steps to keep your product on the market in Europe. It's time to know the essential EU MDR requirements. It's also time to plan and act. The upcoming EU MDR changes are significant, potentially impacting your device classification…

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March 2018

R&Q Intelligence Series Webinar: Risk Management Updates

March 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q on March 27 for their Intelligence Series Webinar: Risk Management Updates. This webinar will provide the background and requirements that medical device manufacturers will need for creating, updating or otherwise remediating the risk management files to meet the requirements of the European Medical Device Regulations (EU MDR), In vitro Diagnostic Regulation (IVDR) and other worldwide requirements. This presentation is designed to set the foundation for your medical device risk management files in alignment with Clinical Evaluation Reports…

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April 2018

R&Q Webinar: EU MDR – Proactive Post-Market Surveillance

April 24, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for April's free Intelligence Series webinar: EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. The session will be on Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not. Webinar details The EU MDR lays out requirements for a proactive post-market surveillance system that that inputs into the ongoing…

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May 2018

R&Q Intelligence Series Webinar: CERs – Tips, Tricks, and Lessons Learned

May 22, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar CERs – Tips, Tricks, and Lessons Learned on May 22 at 1pm. You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs. And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done? In this webinar, you’ll get the clinical…

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September 2018

R&Q Webinar: Wait, what? That’s a combination product?

September 25, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on September 25 at 1pm. Is there a medical device hiding in your product portfolio? Combination products – defined in 21 CFR 3.2(e) – are often stealthy, and once you’ve discovered one, do you know what to do? This webinar will answer those questions and more. After defining what constitutes a combination product and examining other vital basics, we’ll share numerous case studies that shed light on how other companies of different sizes…

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October 2018

R&Q Webinar: Understanding EU MDR and the Roadmap to Compliance

October 23, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on October 23 at 1pm. The EU MDR date of application is approaching faster than you might think. With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information out there, it can be difficult to understand the impact of the new regulations and determine where and when to start. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more…

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November 2018

R&Q Webinar: Economic Operators

November 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on November 27 at 1pm. The EU MDR extended the responsibilities of those who handle your information and product, and require you have new systems to interact with them throughout the process. In this webinar we will cover the requirements for authorized representatives, importers, and distributors. We'll also cover what you as the manufacturer need to do to ensure that these entities are prepared and ready for implementation. Key webinar takeaways: Your role…

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January 2019

R&Q Webinar: EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

January 16 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

BioOhio member R&Q is teaming up with Greenlight Guru for a webinar you won't want to miss on January 16th at 1pm ET! In May of 2017 the European Union’s Medical Device Regulation came into force and with that came a three year transition time which ends on May 26th, 2020. But despite the fact that we’re over 50% of the way through the transition, there continues to be anxiety and confusion surrounding how to interpret the EU MDR, what it means to…

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February 2019

R&Q Webinar: What is sufficient clinical evidence to meet the EU MDR?

February 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar What is sufficient clinical evidence to meet the EU MDR? on February 26 at 1 pm. The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all…

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March 2019

R&Q Webinar: Biocompatibility: EU MDR and the changing regulatory landscape

March 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on Biocompatibility on March 26 at 1pm EST. This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of…

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April 2019

R&Q Webinar: EU MDR for Combination Products

April 23 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q on Tuesday, April 23 at 1pm ET for this month's free webinar: EU MDR for Combination Products. Fresh off of their recent Advanced EU MDR and CER Workshops in Minneapolis and Boston, R&Q's Director of Regulatory Affairs Nancy Morrison will be presenting. The rules have changed with Article 117 and more companies will require notified body involvement. This is the first time devices integral to a drug product will require notified body assessment. Although the requirements…

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May 2019

R&Q Webinar: Integrating CERs and Post-Market Surveillance

May 28 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar Integrating CERs and Post-Market Surveillance on May 28 from 1-2pm. CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports. R&Q will explain how the data inputs and…

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