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.
How we support medical device organisations
Structured support at every stage of development and compliance.
Our Bespoke Audit Process
Internal audits are checked at every surveillance.
We provide independent audits shaped by real certification experience, not box-ticking. Our work covers ISO 13485, MDSAP, ISO 14971, EU MDR/IVDR, FDA 21 CFR 820/QMSR, and international schemes including Canada, Australia and Japan.
Having sat on both sides of the audit table, we know what assessors look for and how findings land when you're the one receiving them.
Software as a Medical Device (SaMD) and Artificial Intelligence (AIaMD) as a Medical Device Regulatory Strategy
Developing SaMD and AIaMD can be complex, things can move really quickly.
These devices in particular require a pragmatic, risk based approach in managing the development and regulatory strategy.
Design Control
No user needs?
No medical device.
We build and run design control that stands up: planning, inputs, outputs, verification, validation, design transfer and change control. Anchored in ISO 13485 clause 7.3, FDA 21 CFR 820/QMSR, ISO 14971, and IEC 62304 for software.
We know the difference between a DHF that looks complete and one that actually demonstrates control, because we audit them and we build them.
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.
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.
MDSAP Audit Support
One audit can satisfy five regulators.
We help you ensure it does.
We assess your QMS against all 7 MDSAP chapters, help you scope task applicability and audit duration, and prepare you for how MDSAP actually grades nonconformities. If you're going global on one audit, we help you get there properly the first time.
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’.”
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.
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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