Notified Body & regulatory inspection support for medical devices

Inspection support services

Notified Body and regulatory inspections are critical milestones for medical device and combination product companies, determining market access and ongoing compliance. Inadequate preparation can lead to delays, non-conformities, delays, and even product recalls.

Our expert consultants provide the strategic guidance and hands-on support needed to navigate audits and inspections with confidence.

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Compliance and peace of mind during external inspections

Our consultants bring extensive industry experience to help you:

  • Identify potential compliance risks before inspections occur.
  • Train staff to handle auditor questions and requests confidently.
  • Ensure quality documentation is complete and up to date.
  • Provide expertise and real-time support during audits and inspections to facilitate smooth interactions with notified bodies and regulators.

Why use our support in inspections?

Successfully passing regulatory inspections requires in-depth knowledge of applicable standards, meticulous preparation, and the ability to respond effectively to findings. Our services include:

  • Pre-Inspection Readiness Assessments – Conducting gap analyses and mock audits to identify and resolve compliance issues, Ensuring your QMS aligns with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
  • Notified Body & FDA Inspection Support – Preparing documentation, training teams, and assisting with real-time audit responses.
  • On-Site & Remote Support During Inspections – Providing expert guidance during regulatory audits to ensure smooth communication with inspectors.
  • Post-Inspection CAPA & Remediation – Assisting with corrective actions, remediation plans, and follow-up reporting to resolve any findings.

 

With our expert support, you can approach Notified Body and regulatory inspections with confidence, ensuring compliance while minimising disruption to your business operations.

Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.