Quality System Auditing Services for FDA,ISO & MDSAP Compliance

Ensure Flawless Quality: Medical Device QMS Audit Services for FDA, ISO & MDSAP Compliance

Overview:
 


In the world of medical devices, quality is paramount. At Noblitt & Rueland, we offer comprehensive medical device quality system (QMS) audits to help you achieve and maintain compliance with FDA 21 CFR Part 820, ISO 13485 and MDSAP (Medical Device Single Audit Program). We also assist manufacturers with their vendor audits and help manufacturers prepare for their inevitable FDA inspection by conducting a Mock FDA Inspection by a former FDA investigator.

Our team of seasoned auditors brings a meticulous eye and in-depth understanding of regulatory requirements. We conduct thorough assessments of your QMS, identifying any potential gaps or areas for improvement. This proactive approach minimizes risk and ensures your processes are optimized for consistent production of safe and effective medical devices. Audits can be completed on-site or virtually as necessary or as requested.

Don't wait for an FDA inspection or Notified Body audit to discover non-conformities. Internal auditing and vendor auditing are extremely important compliance activities in the avoidance of FDA enforcement actions and are cited repeatedly in FDA Warning Letters to manufacturers. Notified bodies also verify that internal and vendor audits have taken place when inspecting for ISO registration, CE Mark approval, or MDSAP (Medical Device Single Audit Program). Partner with Noblitt & Rueland for a proactive QMS audit. We empower you to build a robust quality system, fostering patient safety and building trust with regulatory bodies.



Request an Audit proposal for your company today.