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BioOhio FDA Regulatory 101 Series: Medical Device Testing, Emerging Trends and Regulatory Expectations

September 28, 2016

BioOhio and partner organization MAGNET, are pleased to announce Medical Device Testing, Emerging Trends and Regulatory Expectations. This event will be presented by BioOhio member company LexaMed, and is part of BioOhio’s ongoing series of medical device “FDA Regulatory 101” events.

Each session of the FDA Regulatory 101 Series will cover a spotlight topic along with basic regulatory and quality principles. This cost-effective series is geared toward small and start-up companies, junior regulatory and quality staff, medical device development and manufacturing staff, or even seasoned regulatory and quality professionals wishing to brush up on current trends and expectations.

The challenges and regulatory expectations associated with medical device testing are often very dynamic. This dynamic situation can often lead to unexpected and unwanted discussions/observations/rejections associated with product submissions and/or regulatory audits.

Are FDA expectations changing with regard to certain testing; for example, reusable device cleaning and disinfectant validations? Will new in vitro skin irritation test substitutes be acceptable to FDA and recognized by ISO? Do AET test procedures and end point criteria require better definition? What are the current FDA expectations for the use of environmental microbial isolates? What is the best approach for handling OOS/deviations at a contract laboratory?

These and other issues will be discussed in this presentation using personal experiences and case studies to help illustrate and better explain the situation.


  • 2 – 2:30 – Registration & networking
  • 2:30 – 2:40 – Welcome by BioOhio and Ascend
  • 2:40 – 4:10 – Presentation by Robert Reich, President, Lexamed
  • 4:10 – Event concludes
  • 4:10 – 6:00 – BioOhio Networking Social


  • $50 BioOhio Member (companies w/ 10 employees or less)
  • $100 BioOhio Member (companies w/ 11+ employees)
  • $225 for non-members
  • $25 for BioOhio Student Members
  • Click here to register

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Featured Speaker


Robert Reich, President of LexaMed, is a microbiologist with over 40 years of experience in the healthcare industry in the areas of Management, Validation, Quality and Regulatory Affairs with extensive experience in both pharmaceuticals and medical devices.

He has been co-chair of HIMA technical committees on packaging validation and sterilization monograph review, as well as a member of task groups drafting guidelines on biological and chemical indicators, bioburden quantitation and microbiological methods for the assessment of packaging integrity. He has served as co-chair of ANSI/AAMI Industrial EO committee as well as a member of ISO/ANSI/AAMI technical standards committee on Biological Indicators, product EO residuals, alternative chemical sterilants, packaging, microbiological methods and aseptic filling. He has served as a member of the PDA task force drafting guidelines.

This event is a part of the [M]EDNEXT series. Presented by MAGNET, in partnership with BioOhio, [M]EDNEXT is a program designed to connect established manufacturing companies to critical biomedical knowledge and resources that will help them diversify their revenue streams by entering the growing medical manufacturing industry to create jobs and strengthen the local and state economy. The series is sponsored by JPMorgan Chase. Learn more about this series here.

Complimentary registration is available for auto or aerospace suppliers interested in becoming a medical device supplier. Contact jgoldsberry@bioohio.com for the discount code.