In the previous Podcast of this series, Chris Montalbano, CEO of MIDI, provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. He “opened up” the map with us and explained there are three key stops along this journey. We have already reviewed the first 2 stops which did not need to be deployed under the FDA-QSR and ISO-13485 Design Controls and Risk Management. These activities support a programmatic quality feedback loop as well as mitigate risk for Stop #3 of the Innovation Roadmap (Commercialization & Implementation) which does need to be deployed under FD-QSR & ISO 13485, and is greatly detailed in this episode.
In this methodical process, MIDI's DevelopmentDNA™, ISO-13485 compliant process details each step in Commercialization & Implementation (Stop 3) under Design Controls and Risk Management.
The steps include instituting:
- Plans
- Requirements
- Risk Control
- Design Inputs
- Verification
- Validation
- Engineering & Commercialization activities keyed to the items noted above.
