QMS Internal and Supplier Audits

Medical device manufacturers are required by the ISO and FDA regulations to conduct ongoing audits of their Quality Management Systems as part of maintaining the QMS. In addition, they must audit critical suppliers annually. Using an experienced medical device consultant who is a Certified Biomedical Auditor as your internal auditor, can bring valuable external perspective to your QMS while eliminating bias or conflicts of interest resulting in insights and actions that can improve product quality, facilitate successful FDA inspections and ISO certification audits and ensure that your QMS processes continue to be effective.