Medical device quality & regulatory consulting
Getting compliant devices to market.
Independent, hands-on support for medical device companies, from building a quality system to preparing regulatory submissions.
Get in touch Taking on a limited number of projectsHow I can help
01
Quality management systems
ISO 13485 implementation, procedure writing, internal audits and audit readiness.
02
Regulatory strategy
Classification, pathway planning and submissions for EU, UK and USA markets.
03
Technical documentation
Technical files and design history files that stand up to regulatory body review.
04
UK clinical investigations
Support with UK clinical studies for medical devices, from understanding the pathway to compiling MHRA clinical investigation submissions.
Get in touch
Have a project, an upcoming audit or a regulatory question? Send a short note and I'll get back to you.