Audits
An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device manufacturers the first audit of your processes can be nerve-racking. Finding yourself on an FDA watch list could frighten away potential customers, investors, and potentially cripple the company.
Realistic Quality Solutions serves clients all over the globe performing mock FDA audits in preparation for FDA and ISO inspection audits.
Your RSQ auditor will inspect individual departments and ensure that all actions comply with the compay’s standard operating procedures. If a department or area is not in compliance or in need of improvement, RSQ will work with the company to develop a remedial action plan in conjunction with department managers.
“As a result of the RQS audit, we were able to focus on areas where the audit showed we were weak. We beefed-up our employee training and processes as a result. Three months later we passed our real FDA audit with no findings.”
