ABOUT US
For nearly a decade, DevicePharm Consultancy has supported medical device innovators in navigating complex regulatory and quality landscapes across the UK and Europe.
We work with companies developing traditional medical device, software as a medical device and diagnostic innovations - helping them move from concept to compliance with confidence.
Unlike traditional consultancies, we go beyond delivering checklists and reports. We build sustainable quality and regulatory systems that enable teams to achieve market access and maintain compliance as they grow.
Our team of consultants brings deep assessor-level expertise, gained from years of experience with Notified Bodies and industry leadership roles. That means we understand not just what regulators expect, but also what actually works in practice for organisations.
OUR SERVICES
Our Services
Regulatory Compliance
We simplify MDR, IVDR and UKCA requirements from strategy to submission. Our team makes complex regulations clear and actionable. We deliver regulator-ready files and help you achieve compliance with confidence.
Quality Management Systems
We build ISO 13485 systems that work in practice, not just on paper. Our solutions are sustainable, pragmatic and tailored to your organisation. Structured to scale as your organisation evolves.
Audits & Training
We prepare your team for regulatory scrutiny with clarity and confidence. From internal audits to hands-on QA/RA training, we help embed good practice. The result: stronger systems and a culture of compliance.
Strategic & Expert Advisory
We provide regulatory insight that shapes strategy, not just compliance. Our team supports legal, clinical and executive functions with expert guidance. We conduct regulatory due diligence for organisations acquiring or investing in medical device companies, identifying risks and opportunities with clarity and precision.
TESTIMONIALS
