Independent Medical Device Auditing, for organisations requiring truly objective assessment
External audits across ISO 13485, MDR, MDSAP and related standards: delivering independent evaluation of quality and regulatory systems before regulators or notified bodies arrive.
Audits should be independent.
In practice, they often aren’t.
Many organisations rely on consultancy firms to perform internal audits. While convenient, this can blur the line between advisory work and objective assessment.
Regulators expect audits to be structured, independent and capable of identifying real issues within the quality system.
For organisations operating complex regulatory environments, multiple products, sites and international standards, maintaining that independence internally can be difficult.
Independent auditing provides the objectivity required to understand how systems are truly performing before regulators or notified bodies arrive.
How we support organisations
Support designed to guide devices through certification and into the European market
Full-Scope Compliance Audits
Independent audits across ISO 13485, ISO 14971, IEC 62304, MDR, IVDR and MDSAP frameworks.
Technical Documentation Reviews
Assessment of technical files and regulatory documentation ahead of external review.
Regulatory Readiness Assessments
Independent evaluation of quality systems ahead of notified body or regulatory inspections.
Supplier and Multi-Site Audit Programmes
Co-ordinated audits across distributed manufacturing and supplier networks.
Audit Reporting and Inspection Support
Structured reporting and support during notified body or regulatory review
Why choose The Other Consultants?
Independent auditing shaped by real certification experience.
UKAS-witnessed Lead Auditor
Independent and objective
Certification body and notified body perspective
Over 50 ISO 13485 and MDR audits conducted
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"Just to let you know that today’s audit on design didn’t raise any CARs...
they accepted that we had a strong internal audit conducted and that our QMS was working and flagging issues”
PRRC of a IIa medical device manufacturer.
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“Adam is a breath of fresh air when it comes to QARA...
…he takes the time to understand the needs of a client and communicate effectively. He is not afraid of a challenge and always goes above and beyond to not only ensure optimal results but that the end client "gets it". I highly recommend his services.”
Karandeep Singh Badwal, The Medical Device Podcast
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“I have worked with Adam on several projects...
…relating to Medical Devices his regulatory experience and knowledge are exceptional and always up-to-date in the current climate of regulatory changes.”
Martin Coles, Operations Director - International Associates
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“Adam is a highly knowledgeable Medtech professional...
… who has a passion for the industry and its requirements. Adam hit the ground running supporting my requirements and is always dedicated. Adam brought his background and knowledge as part of a project in Supplier Quality working with critical partners including Six Sigma DMAIC and root cause analysis.”
QuMatthew Clark, European Supplier Quality Manager - CooperVision
“Independent auditing gives organisations an honest view of how their systems are performing. That clarity is what allows teams to prepare properly for regulatory scrutiny.”
Adam Isaacs Rae, Founder
Need independent external auditing?
Independent assessment, for organisations requiring objective audits across complex regulatory environments.