Loading ...

FDA QSIT Mock Inspections and Audits for Medical Device Manufacturers

FDA inspections can come at any time and often with little advance notice. That's intentional because FDA wants to know that you're always prepared for an FDA inspection. Are you? Let’s find out. We can help understand the FDA’s quality system inspection technique (QSIT), determine your state of readiness, and fix what’s broken before the FDA inspector shows up.


How We Help

FDA Mock Inspections (QSIT Audit)

An Oriel STAT A MATRIX FDA mock audit (QSIT audit) is a convenient way to test your internal systems and personnel before an FDA inspection. Using FDA’s quality system inspection technique, our auditors will take on the role of FDA inspectors and dig into your processes. We can also share techniques for efficiently organizing FDA audits and managing multiple inspectors. We will:

  • Prepare an internal audit plan
  • Conduct thorough documentation review, including quality manual and SOPs
  • Conduct a mock FDA inspection
  • Compile findings and report to management team
  • Draft a detailed FDA mock audit report
  • Facilitate a remediation planning session to develop your quality transition plan
  • Assist with closing gaps revealed in the audit, as desired

Uncover Gaps With a Baseline FDA Audit

Conducted at the start of your quality management system (QMS) implementation or as part of a QMS upgrade, a baseline or gap assessment audit analyzes your current level of compliance to relevant quality standards and/or regulations – including FDA QSR, ISO 13485, MDSAP, EU MDR, and EU IVDR. These audits identify areas of noncompliance and conclude with a formal action plan – the roadmap – for achieving compliance. Because we are a consulting and training company, not a certification or regulatory body, our consultants can provide advice on how to remedy nonconformances.

Private FDA Inspection Readiness Training for Teams

There is an art to effectively managing an inspection. Leveraging decades of experience from our technical experts who have hosted numerous inspections over their careers, Oriel STAT A MATRIX has created a workshop-based training that will show you and your team how to effectively set up a front room/back room audit approach and confidently handle anything an FDA inspector throws at you. Learn more here.

We’re Ready to Help

FDA inspections can be a nerve-wracking experience but less so when you feel confident and prepared. Our team has helped hundreds of medical device companies make sure they are fully prepared for an FDA inspection. Let's talk about how we may be able to assist your company as well.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

Get answers right now. Call
us flag

US OfficeWashington DC


EU OfficeCork, Ireland

eu flag

+353 21 212 8530

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal