Voler System’s Walt Maclay will join three leading medical device developers on a panel discussion at the SV Hardware to Scale Meetup a panel discussion on “Medical Device Development for Newbies”.
May 24, 2018 in Mountain View
The free program, Medical Device Development for Newbies, additionally features Jennifer Ernst, CEO at Tivic Health, Jeffrey Christian, CEO of Phoenix DeVentures, and Howard Edelman, CEO of Advanced Resin Therapeutics and co-chair of the medical device and digital health screening committee of Life Science Angels.
Medical device development requires a deep understanding of the FDA regulatory process. The regulations mandate a comprehensive set of capabilities, including documentation, quality controls and risk management. While medical product development generally follows a standard development process, there are unique challenges that must be addressed in this highly regulated industry. Topics to be covered include:
Differences between an FDA regulated and a non-regulated product
Helpful advice for medical device newbies
Sharing the best approaches for funding
Navigating FDA regulations & risk management
Overcoming pitfalls that can delay or derail the development process
Voler’s expert medical device team has decades of design experience on hundreds of projects across a wide spectrum of medical devices. Their multi-disciplinary team knows the regulatory process and procedures and delivers high quality products on time and on budget. Voler Systems is known for their expertise in motion control, wireless technology, wearables, proof of concept projects, test equipment for Class 3 medicals, and regulatory requirements.
If you are interested in learning more about the development of technology based medical products and learning from industry experts what it takes to succeed in this market, then this session is for you.
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New Regulations in CE for Medical Devices | Voler Systems