Products

We have developed a suite of documents that incorporate all of the requirements of ISO 13485. These templates cover all aspects of the quality system including change control, internal audits, device master records, etc.

With some customization to a specific medical device business, these documents can form a drop-in-place quality system saving the client considerable amounts of time and money.

Document templates can be purchased on their own or can be coupled with consulting services to aid in both tailoring the documents to specific needs and most critically in helping the client understand how to implement the quality system so that Quality becomes a part your business processes and not simply an additional documentation burden.