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