1) FORGETTING ABOUT THE USER:- Companies usually forget the main reason why they are developing a product. Failing to include the user in the process often starts right at the beginning of the development process, Ideally, you want to have the user involved in the process of documenting user needs from the beginning.
2)FAILING TO DOCUMENT DESIGN CONTROLS OR DHF:- Sometimes developers get so focused on the end goal that they forget about the process and don’t capture or document what they should.
3)DELAYING IMPLEMENTING YOUR QUALITY MANAGEMENT SYSTEM:- it’s never a good plan to delay setting up your QMS, QMS is a basic requirement and you can expect that FDA or the relevant regulatory authority you’re dealing with will want to examine it in an inspection.
4) NOT DEFINING REGULATORY STRATEGIES:- This is a basic, yet common mistake in that developers underestimate the regulatory requirements that they need to follow for their particular device, or they go ahead and take a guess. And for starters, a lot rides on how your product is classified.
5) NOT KEEPING GOOD RECORDS:- There’s failing to document, but then there’s also documenting things poorly. There is a record keeping element to every aspect we’ve talked about in previous sections and it’s important to do this well.
6) RUSHING HUMAN TESTING:- It’s common to want to get human study done quickly, but companies often haven’t done a thorough job of safety testing first. It’s disturbing how casually this often seems to be treated; particularly, where the company acts as though using a country with less regulations for testing makes it ok. I feel like if you’re using your product on humans! There should be evidence of controls during manufacturing, biocompatibility testing etc., to prove the product is safe first.