Medical Device Auditing, for organisations needing independent regulatory assurance
Objective ISO 13485 and MDR audits conducted by experienced auditors who have sat on both sides of the table; conformity assessment auditor and auditee.
Internal audits are mandatory.
Effective audits are rare.
ISO 13485 requires organisations to maintain an independent internal audit programme covering their quality management system.
In practice, many organisations struggle to maintain the independence, expertise and consistency required. Audit schedules slip, internal teams lack capacity, and colleagues are asked to audit one another.
The result is an audit programme that exists, but doesn’t always provide the objective insight regulators expect.
Independent auditing restores that clarity.
How we support organisations
Independent auditing designed to withstand regulatory scrutiny.
ISO 13485 Internal Audit Programmes
We plan and deliver internal audits aligned with ISO 13485:2016 to ensure your quality management system is assessed thoroughly and independently.
Certification Audit Preparation
We conduct independent audits ahead of Stage 1, Stage 2, surveillance or recertification audits, helping ensure your systems stand up to certification body review.
Independent Internal Auditing
We provide objective audits where organisations lack the independence required to assess their own processes internally.
MDR-Focused Quality System Assessments
We evaluate how your quality system performs against the expectations of EU MDR regulatory environments.
Why choose The Other Consultants?
Independent auditing shaped by real certification experience since 2017.
Experienced certification Lead Auditor
Independent and objective
Conformity assessment considerations
Hundreds of days of 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
“Internal audits shouldn’t be a box-ticking exercise. Done properly, they are one of the most valuable ways to understand how a quality system really performs. ”
Adam Isaacs Rae, Founder
Preparing for an upcoming audit?
If you're preparing for Stage 1, Stage 2, surveillance or MDR review, we can help ensure you‘re ready.