IVD · transition
$250M IVDR programme across nine countries
Programme Manager for a global diagnostics leader, steering the IVDR transition across the USA, UK, Ireland, Norway, Germany, China, Japan and South Korea.
$250M programme value
Proof, not promises
A track record you can check
Worldwide Device Solutions is led by Paul Rowden, with 27 years getting medical devices and diagnostics onto the market and keeping them there. The numbers are the argument.
- 600+
- companies to first time approval
- 15
- FDA inspections
- 0
- warning letters
- 27+
- years in global QA and RA
- UK + EU
- representation, one contract
Signature work
Programmes that set the standard
Orthopaedics · leadership
Interim VP of QA and RA for a global implant maker
Stepped in to lead a 27 person quality and regulatory team on a $2.3M budget, holding the line through audits and approvals.
27 person team led
Inspections · record
15 FDA inspections, zero warning letters
Across nearly three decades and 15 FDA site inspections, not a single warning letter. Files that hold up when the regulator is in the room.
0 warning letters
Outcomes
The breadth behind the numbers
A sample of the device and diagnostic work, across classes and continents.
A proton beam therapy system through full QMS and technical documentation
Led the quality system, technical file and design history file for a Class III proton beam system that targets deep brain tumours. Built to withstand the highest level of scrutiny.
Diagnostics to market at pace, without cutting the corners that matter
From PSA prostate cancer assays to COVID-19 lateral flow, IVDs taken through approval with the evidence and quality system to hold up after launch.
Implants signed off that gave people their mobility back
Knee, hip and spinal implants through QA and RA at director level. One patient stood and danced in a plane aisle to show a team the difference a new hip had made.
500+ CE technical files built and approved
250+ Notified Body audits delivered
30+ countries served
Named credibility
Trusted on devices and diagnostics for
Includes interim VP of QA and RA for a global implant maker, and Programme Manager on a $250M IVDR transition across nine countries.