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How we support medical device organisations
Structured support at every stage of development and compliance.
Medical Device Auditing
Internal audits are mandatory.
Effective audits are rare.
We provide independent ISO 13485 and MDR-focused audits shaped by real certification experience.
Led by a UKAS-witnessed, BSI Certified Lead Auditor with over 50 completed audits, our approach reflects what certification bodies and notified bodies actually examine.
Person Responsible for Regulatory Compliance (PRRC)
PRRC is a legal requirement. Accountability is personal.
We act as your PRRC under MDR and IVDR, providing structured oversight across product conformity, technical documentation and post-market obligations.
Our role keeps responsibility clear, proportionate to your organisation and continuously maintained.
CE Marking & European Market Access Strategy
No certification.
No Market.
We support classification, regulatory pathway planning, technical documentation and Notified Body engagement from the outset.
Our approach helps you reach the EU market deliberately, with systems and evidence built to withstand scrutiny beyond certification.
ISO 13485 Internal Audit Scheduling Tool
Gaps in your audit programme can become findings.
Our ISO 13485-aligned tool guides you through scope, risk and audit history to generate a structured, prioritised audit schedule.
It reduces slippage, strengthens oversight and helps teams stay aligned to clause 8.2.4.
Independent Medical Device Auditors
Conflicted audits weaken credibility.
We deliver fully independent, risk-based audits across ISO 13485, ISO 14971, IEC 62304, MDSAP and EU MDR/IVDR: objective, defensible and regulator-ready.
A breath of fresh air
“They’re not afraid of a challenge, and always go above and beyond to not only ensure optimal results but that the end client ‘gets it’.”
Why Us?
We have led over 50 certification and regulatory audits, working directly with certification bodies and notified bodies.
That experience shapes how we advise: not from theory, but from assessment under real scrutiny.
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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
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