Audit and Inspection Readiness

Prepare for your next FDA inspection or notified body audit or get experienced support when one is already underway. NSF brings extensive inspection and audit experience, with teams that can include former FDA employees and investigators. We help you identify compliance gaps, strengthen inspection readiness, manage active inspections and respond to inspection findings.

How can you prepare for an upcoming regulatory inspection?

Whether you are preparing for an FDA inspection, an EU MDR or IVDR notified body audit, an MDSAP audit or another regulatory inspection, NSF can help you identify compliance gaps, prepare your team and documentation, and organise the inspection process.

Find gaps before inspectors do

Gap assessments, QMS review, FDA, ISO 13485, EU MDR/IVDR, MDSAP

Before an auditor or inspector reviews your quality management system (QMS), a gap assessment can help identify deficiencies in processes, procedures and records. We assess your documentation and practises against applicable requirements, then identify the areas that need attention.

Depending on your needs, the assessment may address FDA Quality Management System Regulation (QMSR), ISO 13485, EU MDR or IVDR, or MDSAP requirements. The findings give your team a practical basis for addressing gaps ahead of an audit or inspection.

Talk to an audit and inspection expert

Ensure your team knows what to do on day one

Roles, responsibilities, front room/back-room processes, document control and escalation

Your team needs clear responsibilities when inspectors arrive. We help prepare personnel and documentation, establish who communicates with inspectors, assign responsibility for retrieving and reviewing records, and plan how requests and issues will be tracked and escalated.

An audit playbook brings those responsibilities together, including how your front room and back room coordinate during an inspection. It gives your team a practical reference for handling requests and maintaining clear communication.

Experience the inspection before it happens

Mock FDA inspections, notified body audits, MDSAP preparation, post-market readiness

Mock inspections and audits help your team evaluate its readiness before an external inspection or audit. For FDA inspections, NSF can simulate investigator questions, record requests and coordination of responses, helping you see how your team performs under inspection conditions. Our mock FDA inspection services can include hats-on, hats-off approaches.

For EU MDR and IVDR notified body audits, we can support your team through EU MDR compliance audits.

For MDSAP audits, we can review QMS processes, records, and objective evidence relevant to the markets included within your MDSAP certification scope.

Managing an active FDA or regulatory inspection

When an inspection is underway, your team must respond quickly, maintain clear communication and keep documentation organised. NSF provides onsite and remote support to help you coordinate requests, obtain subject-matter expertise and manage responses to inspector questions and observations.

We can support both front-room and back-room activities, helping your team track requests, review records before submission, coordinate internal stakeholders and maintain an efficient inspection process.

For FDA inspection readiness preparation or back-room support, our team can include former FDA investigators, former industry quality and compliance leaders, and former MHRA inspectors. Their experience helps your team navigate inspection requests, manage escalating issues and maintain a coordinated response throughout the inspection.

Contact us to discuss your audit and inspection needs. See how NSF helps life sciences companies strengthen compliance, prepare for inspections, and reduce regulatory risk.