I recently got promoted from being a Technical Support Specialist to being the one and only person in my company to handle our Quality Management System including the regulatory side of our product design and development. I have no background, no training, just been learning from our QMS consultant and the internet. To top things off I have a prototype medical device that I need to figure out the regulatory side of as we likely will need to submit at least an abbreviated 510(k) if not a traditional. And there is no documentation that was followed for the prototype so I have to figure out what is required and fill in our gaps. Our prototype device is non-contact, non-invasive.
Does anyone have recommendations for resources of information? Our QMS system was just overhauled by a consultant and at this point is at the bare minimum so I don't have a lot of SOP's or work instructions to help me out. I've found the FDA Guidance on 510(k) filing but that doesn't always help with filling out the individual document such as the input-output traceability matrix. I feel quite a bit in over my head, and would appreciate any guidance or resources. We are mainly dealing with FDA regulations currently but we are looking at getting an ISO 13485 certification in the next year.
Does anyone have recommendations for resources of information? Our QMS system was just overhauled by a consultant and at this point is at the bare minimum so I don't have a lot of SOP's or work instructions to help me out. I've found the FDA Guidance on 510(k) filing but that doesn't always help with filling out the individual document such as the input-output traceability matrix. I feel quite a bit in over my head, and would appreciate any guidance or resources. We are mainly dealing with FDA regulations currently but we are looking at getting an ISO 13485 certification in the next year.