Paul Rowden
Founder and Senior Regulatory Partner
27 years in global QA and RA for devices and IVDs. 600+ companies to first time approval, 15 FDA inspections with zero warning letters, and over 500 CE technical files built and approved.
About
The senior partner you actually get to work with
No account managers, no juniors learning on your file. When you work with Worldwide Device Solutions, you work directly with the person who has done this 600+ times.
Paul Rowden Founder · QA / RA Compliance Partner
- 600+
- companies to first time approval
- 15
- FDA inspections
- 0
- warning letters
- 27+
- years in global QA and RA
- UK + EU
- representation, one contract
Nearly three decades of getting it right
Paul Rowden has spent more than 27 years in global quality assurance and regulatory affairs for medical devices and in vitro diagnostics. In that time he has taken over 600 companies to first time approvals across FDA 510(k), CE, UKCA, ISO 13485, MDSAP and CMDR, and built more than 500 CE technical files, every one approved.
He has stood in front of the FDA 15 times for site inspections and never taken a warning letter. He has led at director and VP level for global names, stepping in as interim VP of QA and RA for a major implant maker, and run a $250M IVDR transition programme across nine countries.
The work spans orthopaedic implants, cardiovascular stents, proton beam therapy, stem cell cryopreservation, and a wide range of diagnostics from PSA prostate cancer assays to COVID-19 lateral flow. Breadth that means very little is genuinely new.
Why this work matters
Years ago, Paul helped develop a PSA test, the kind of diagnostic that catches prostate cancer early. Later, he lost his father to that same disease, caught too late.
It is why he sees regulation the way he does. Not as paperwork, but as the bridge between an innovation and the patient who needs it. A device that does not reach the market helps no one. Getting it there, safely and on time, is the whole point.
The team
Senior people, not a sales desk
A small group of specialists who have each spent decades in regulatory affairs. Whoever you work with on your file is the expert, not a coordinator passing it on.
Jeff McBride
Associate Software Consultant
30+ years in healthcare technology compliance and a subject matter expert in mobile health. Pioneered mHealth certification, including early CE marked health apps, with recognition secured from the MHRA, HPRA and FDA. ISO 13485 and ISO 27001 accredited.
Diarmuid Cahalane
Associate Consultant
Internationally recognised expert in compliant healthcare technology. Founded his regulatory consultancy in 1996, specialising in computer systems validation and laboratory certification, and co founded Metabolomic Diagnostics. Advisory board member for CODEX4SMEs and an Enterprise Ireland mentor across digital health, IVDs and digital pathology.
Dr Abdul Waheed
Clinical Evaluation and Regulatory Affairs Consultant
Subject matter expert in clinical evaluation, clinical evidence strategy and global regulatory affairs, with over 15 years across medical devices, IVDs, pharma and biotech. Authors clinical evaluation plans and reports, technical files, risk management, biological evaluation and PMS and PMCF documentation for CE and UKCA certification under EU MDR and IVDR. An ISO 13485 Lead Auditor who turns complex regulatory challenges into clear, compliant routes to international markets.
Sam Bacon
Associate Software Consultant
Builds quality management systems to ISO 13485 for Class I to IIb devices and software as a medical device. Strong on FDA submissions, MDSAP, risk management to ISO 14971, UDI and EUDAMED, and NHS market access. ISO 13485 certified internal auditor.
Andy Bodinner
QARA Consultant and Director, QARA Huntcliff
23+ years across health and social care with a nursing background, mentored by Paul. Specialises in building ISO 13485 systems, MDR, UKCA and CE marking, technical files, risk management and regulatory support for startups.
Jamie Bellhouse
Medical Device Consultant and Business Development Manager
Over a decade in QA and RA, trained under Paul, building technical files and design dossiers to ISO 13485, MDR and IVDR and 510(k) submissions for the FDA, for clients from startups to Zimmer. A photographer and videographer by background, he runs the marketing, website and operations, keeping the whole business sharp and efficient.
UK Responsible Person
United Kingdom
Newcastle upon Tyne, England
EU Authorised Representative
Ireland (EU)
Cork, Republic of Ireland
Two offices, one team. The UK Responsible Person in Newcastle and the EU Authorised Representative in Cork sit under one contract, so your whole position across both markets is held in one place.