1. The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?
2. We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS.
I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS
We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners.
We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review.
Can we somewhere buy a core (just enough) QMS that complies with ISO13485?
Your toolkit is much more than we need, do you have a core toolkit as well?
3. Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.