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.

NAMSA and the Regulatory Affairs Professional Society (RAPS) will hold this webinar to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.

Grab your favorite drink (or just a drink), come learn and interact with industry experts while they discuss hot topics in Medtech. This session: Navigating the Complexities of the US Healthcare Reimbursement System

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.

Please join Bristol Myers Squibb (BMS) for a virtual policy forum on the Inflation Reduction Act. The forum will bring together patient and professional advocates with internal BMS experts to deliver a brief overview and timeline of implementation of the healthcare policies in the new law.

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.

The Cell & Gene therapy market is poised to undergo significant growth over the next 2-5yrs growing from a $1B market in 2018 to a ~$9B market by 2025. However, we anticipate finding qualified talent will become a critical roadblock to bringing innovative new therapies to market. Kelly Science & Clinical, the 2nd largest Science staffing agency, is taking the lead to address this challenge head-on by hosting the second installment of (Ex)2: The Expert Exchange Series, Accelerating Cell & Gene Therapy Careers. We will bring together well-known industry experts along with our own experts to discuss the growing talent needs and share with candidates insights and job opportunities for them to ride this wave to accelerate their careers in cell & gene therapy.

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering the Combination Products Summit. The AFDO/RAPS Healthcare Products Collaborative combination products community continues to be led by top FDA officials and worldwide industry leaders who built the framework for the regulatory landscape of combination products. This global community drives innovation and navigates the complexities specific to the world of combination products, resulting in the delivery of safe, effective, and high-quality products to the patients who need them.