Your strategic partner in medical device development from design to market access
We turn innovation into approved medical products, by shaping your regulatory strategy through design control, clinical evidence, quality systems and certification.
Support shaped by audit expertise, on both sides of certification.
We’ve witnessed how promising technologies falter when structure is missing, and how they pause when regulatory, clinical and quality strategy are aligned from the outset.
Founded by Adam Isaacs Rae, a UKAS-witnessed, BSI Certified Lead Auditor who has led over 50 ISO 13485 and MDR audits, our approach is built on direct experience working with certification and notified bodies.
We align design, clinical evidence and regulatory strategy early: so when your device is reviewed, it stands up. Fundamentally, we make sure your device has a clinically relevant and visible pathway to market.
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 audits shaped by real certification experience — not box-ticking against a checklist. Our work spans the standards and regulations that actually govern your QMS, including ISO 13485, MDSAP ISO 14971, EU MDR and IVDR, FDA 21 CFR 820 / QMSR, and global schemes such as MDSAP, Canada's CMDR, Australia's TGA requirements, and Japan's MHLW ordinance.
Having audited on behalf of certification bodies, and sat on the other side of the table as an auditee, our audits bring insight from both sides: we know what assessors look for, and we know how findings land when you're the one receiving them.
Our audits and competency reflect what notified bodies and certification bodies actually examine — and where findings really come from.
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’.”
Who We Work With
We work with medical device organisations operating under regulatory scrutiny, including early-stage companies preparing for their first certification, scaling SMEs navigating MDR or IVDR transition, and established manufacturers strengthening their quality and compliance systems.
Want regulatory strategy that is clear, defensible and commercially grounded?
That’s our bread and butter.
“I’ve spent much of my career inside audits and certification reviews. When organisations prepare properly, those assessments become constructive: not something to fear.”
Adam Isaacs Rae
Founder
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
Building something that matters for patients?
If you’re preparing for certification, strengthening your QMS or formalising regulatory accountability, we’re here to help.
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