This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. In an effort to provide quality programming in the safest and most effective manner possible, the Conference will once again be held virtually this year. Dates: Wednesday, May 11th – Friday, May 13th

ARM, in partnership with BioOhio and JobsOhio, will hold its first state event in Columbus in May, showcasing Ohio’s leadership in creating a hub for the cell and gene therapy field. The event will include a panel discussion from 4:00 pm – 5:00 pm, followed by a reception from 5:00 pm – 7:00 pm.

Harrington Discovery Institute accelerates promising discoveries into medicines for unmet needs focusing on Major Diseases, Brain Health Medicines, COVID-19, and Rare Diseases. Our work endeavors to improve human health and better our world. We are driven by passion, innovation, and integrity, to cure diseases together.

Join NAMSA for this webinar as we walk through the key differences between EU’s In Vitro Diagnostic Directive (IVDD) and IVDR and the clinical study requirements outlined within these regulations. We will also examine ISO 20916:2019 as the Good Clinical Practice (GCP) guidance for IVD clinical performance.

Join BioOhio and Project Medtech for a fun networking social in Cleveland, Ohio! This event will bring the region’s life science community together for networking and connecting. We’ll be at local gem and member Saucy Brew!

A dramatic shift in regulatory opinions has occurred within the last several years regarding the concepts of Extractables and Leachables (E&L) testing of medical devices, commonly known as Chemical Characterization. Much of that change was driven by the 2020 revision to ISO 10993-18. Join NAMSA for this webinar to learn more about the foundations behind Chemical Characterization and to examine best practices deriving from it.

Please join us for an industry-wide briefing to discuss the importance of SBIR/STTR programs and the status of Congressional reauthorization. On September 13, AdvaMed Accel, SMTA, BIO, and CSBA will co-host a webinar to discuss the success of SBIR/STTR programs, the next steps to reauthorization, and Federal agencies’ approach to a potential lapse in program authority.

MD+DI and Qmed present “Choosing a Medical Device Contract Manufacturer with the Right Quality and Regulatory Credentials.” Join Spartronics Site Leaders Casey Cramer, and Ryan Carlson, on Thursday, September 15th at 2:00 PM ET for a live webinar hosted by industry leader MD+DI. The two will discuss the importance of selecting a medical contract manufacturer with the right quality and regulatory credentials to support the manufacturing of medical devices. As Site Leaders of focused medical facilities, they’ll touch upon the various quality and regulatory credentials for electronic and electromechanical medical devices. Additionally, they’ll dive into the value of the Medical Device Single Audit Program (MDSAP) and its impact on medical device contract manufacturing.

Join us as Agilent technical experts provide you with the valuable tools needed to accelerate your instrument towards unmatched performance and productivity. This seminar is designed to give you real-world knowledge that can be applied immediately in your lab. You are invited to join us for a half day or you can attend both the LC and the GC sessions. Registration is free but seating is limited. ** There are three events touring the state of Ohio: Southwest Ohio 9/20 (Mason) | Central Ohio 9/21 (Powell) | Northeast Ohio 9/22 (Independence) **

The role of biostatistics during a clinical study is often underestimated and viewed merely as a black box of providing statistical inputs at the end of a trial. However, partnering early and often with a Biostatistician on the design of your IVD clinical trial can help avoid costly mistakes, such as inadequate data collection, inefficient data pipelining and data cleaning. Join NAMSA for this webinar as we examine these critical areas, provide insight on how to prevent unnecessary delays and walk through two real-world case studies.