
Deflating Common QMS Misconceptions: Your Transition from Class II to Class III Devices
August 29, 2019
by Andrea Pilon Artman, Founder, SpectRA Compliance
Medical device manufacturers are often confused about the regulatory requirements when expanding their product line from Class II devices to also include Class III devices. Learn what is and what is not required of your quality management system (QMS) and premarket approval application for Class III devices.
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