Contributor-CGibsonBioOhio welcomes a new contributor to micrOHscope! Chad Gibson, Project Engineer with R&Q, has years of experience in the medical and in vitro diagnostic device industry. He and the team from R&Q are partnering with BioOhio to produce the Regulatory 101 Series. Thanks again to our event sponsor, Schulman Associates IRB, guest speaker Mark Bode of Joey Medical, and our hosts, the City of Mason.

Post-2015-1-30-Reg101We had a great turnout at the first Regulatory 101 event in Mason last week. As the name implies, we covered the basics of medical device regulation, but we designed the series to benefit both new and seasoned medical device professionals. We walked through the complete medical device life-cycle, from feasibility to post-market surveillance. We also touched on current trends like cyber-security, usability engineering, and medical device apps.

Mark Bode, CEO of Joey Medical joined us during lunch to speak about his experience being an entrepreneur going through the regulatory system, and delivered valuable lessons learned to the audience.

We set out to make the Regulatory 101 series both convenient and an excellent value. Because of BioOhio’s connections, we were able to offer the 4+ hour session for $50 ($100 for non-members), including a lunch. Where else can you get training on medical device regulations for that price, and with less than a day out of the office?

“I really enjoyed the session and felt all information presented had a very practical application to our business.” said Michelle Adamski, Quality Assurance and Regulatory Affairs Manager, Products, NAMSA. “I love that there is a resource in Ohio without having to travel great distances! I look forward to attending the other sessions planned for this year.”

If you missed this one, don’t worry. Regulatory 101 will be hosted in three other Ohio cities this year: Cleveland in April, Columbus in July, and Dayton in November. Dates and registration details will be announced soon. We’ll still cover all of the basics, but will present a different spotlight topic at each session.

Regulatory-Quality-400We believe events like this are critical to Ohio’s success. Regulatory and quality gatherings in our own state are one way we can get a leg up on medical device hubs like Boston, Minnesota, and Southern California. Practical knowledge of quality and regulatory topics helps start-ups and small companies become both compliant and efficient, and large companies build and maintain internal expertise.

With the combination of the BioOhio Regulatory Forum, the Regulatory 101 series, and MedCon, Ohio is building a strong medical device quality and regulatory foundation that benefits all of us!

Schulman-Associates-IRB-400    Joey-Medical     City of Mason