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.
MDMA's Medical Technology Executive Forum will deliver key insights on regulatory, reimbursement and other issues facing our industry. BioOhio members can receive $100 off the non-MDMA-member registration rate. Contact BioOhio staff for your discount code.
Join us on September 27th to explore What Now, What’s New & What's Next. Preview exciting, next-generation innovations, hear technology trends and insights directly from industry experts, learn about the resources available to transform ideas into powerful products, and meet entrepreneurs contributing to the health and prosperity of our communities. One of the largest not-for-profit healthcare system in the U.S., ProMedica is recognized for unmatched clinical care and dedication to innovation. The 2022 ProMedica Innovations Summit will explore exciting advances and the many dimensions of health and wellbeing, including a dynamic afternoon discussion around longevity. Don’t miss your chance to meet other changemakers. From the kickoff breakfast on, this day of celebration, education and community is filled with networking opportunities.
Presented by The Alliance for Regenerative Medicine, The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Save the dates for next year’s conference October 11-13, 2022!