Join NAMSA for this webinar as we walk through an overview and understanding of the ISO 14155 standard changes, discuss how this compares to the previous 2011 version and explore why adoption, planning and implementation are key to commercial success.
Join NAMSA and the U.S. Food and Drug Administration (FDA) as we present this upcoming webinar on July 20, 2022, regarding the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA. During this webinar, the FDA will highlight how the ASCA Pilot Program streamlines aspects of conformity assessments for medical device submissions, as well as what manufacturers can expect when they submit ASCA test results to the government agency.
Join us on July 28 for the inaugural Ohio HealthTech Summit brought to you by OhioX and University Hospitals Ventures. This virtual event will take a deep look at the latest technology trends and activities happening in Ohio’s rich healthcare innovation ecosystem. Topics range from digital and virtual health to emerging technologies like extended reality, AI, and blockchain. Learn how Ohio providers, corporations, entrepreneurs, and investors are partnering to deliver outstanding care to Ohio consumers and communities.
In healthcare, we often hear the phrase “patient focus” which is designed to make decisions with the patient’s safety in mind. But all too often we forget that within the workplace, we also need to consider the safety and well-being of our sterile processing professionals who are facing the risks and doing the real work. This presentation will focus on the dangers and risks we face on a daily basis in our departments as well as provide solutions for those dangers and risks.
The U.S. healthcare market is in a continuous state of flux and uncertainty. Now more than ever, it’s imperative that pharmaceutical manufacturers partner with emerging vendors to overcome the unique market access challenges of rare disease and gene/cell therapies to avoid pitfalls and to drive a successful product launch. During this webinar, our experts will provide in-depth insights on commercialization strategy, distribution models and demonstrating therapeutic value of Rare Disease & Gene/Cell therapies for patients, payers, and providers. This event features member Michael Baldzicki, Chief Brand Officer, AscellaHealth.
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.
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 NAMSA for this webinar as we discuss strategies to optimize your preclinical testing with an emphasis on complex Class II and Class III medical devices focused in the cardiovascular therapeutic area. Highlighted will be an overview of cardiovascular device conceptualization, prototype and iterative design, model selection and how to build a foolproof pivotal safety-testing plan.