Hello, could anyone please share strategies for how to establish "design inputs" for a medical device, to satisfy any requirements from government regulations and various international standards?
To develop a Class 2 device for the US market, it must conform to FDA regulatory requirements and FDA-recognized consensus standards for things like biocompatibility, sterilization, etc. It's my understanding that when I'm establishing a document to translate "user needs" into "design inputs", it must include requirements from regulations and standards. So far I can only think of two possible options:
To develop a Class 2 device for the US market, it must conform to FDA regulatory requirements and FDA-recognized consensus standards for things like biocompatibility, sterilization, etc. It's my understanding that when I'm establishing a document to translate "user needs" into "design inputs", it must include requirements from regulations and standards. So far I can only think of two possible options:
- As high-level design inputs, I just write that the device must conform to FDA regulations and each individual standard. Then as a verification method, I write up a lot of long checklists. each stating how my device conforms to FDA regulations and each individual standard. Each checklist would basically be a long list of requirements from the regulation/standard, and would be used to "verify" only a single "design input".
- I painstakingly list every FDA requirement and every standard requirement as individual design inputs. This means I would have an extremely long list of specific design inputs! (It would be a design input for every requirement from the FDA regulations and all the standards). Then as a verification method, I would still have a lot of long checklists but now every item on the checklist was recorded a design input. So each checklist would "verify" a lot of "design inputs" simultaneously.