Keeping Up with Medtech Regulatory Standards

Flexan, Maxon, and Spartronics are sponsoring a webinar that will give engineers and medtech professionals quality insights on navigating the regulatory pathway. 

The series kicks off September 13th with Flexan's Steve Hellstrom discussing "5 Critical Quality Questions You Must Ask a Prospective CMO." The webinar is intended for any Engineer, Quality Professional or Operations Executive who is tasked with choosing a CMO to support their medical device manufacturing.

On September 14th, Maxon's Peter van Beek discusses "Designing for high-risk class MDR & FDA Regulations." When designing and developing motor assemblies for medical devices, there are critical steps which need to be taken, along the path from functional samples to serial production, to ensure compatibility with MDR and FDA regulations. This process involves initially selecting the right products, with correct materials, capable of sterilization, biocompatibility, and environmental conditions.

The series concludes on September 15th, with Spartronics's Casey Cramer and Ryan Carlson touching on the topic of "Choosing a Medical Device Contract Manufacturer with the Right Quality and Regulatory Credentials." Together, they will discuss various quality and regulatory credentials, and will specifically dive into the Medical Device Single Audit Program (MDSAP) its impact on Medical Device Contract Manufacturing.

Click here for more information.