Kenneth S.

I'm a regulatory affairs and quality assurance consultant helping manufacturers maintain or obtain their CE marking for their medical devices and IVDs. - 10+ years of experience in EU and UK regulation. - Clear and frequent communication. - Passion for medical devices! I have helped many device manufacturers enter the EU or UK market, including various SaMD and AIaMD devices, implants (neurovascular, cardiovascular, orthopedic), solution-based products, standard of care devices. Using my many years of experience, I put together documentation that is easily understood by Notified Bodies during assessments; this leads to better results. I help startups and established manufacturers get CE-marked, guide clients through gap assessments, technical file compilation, PMS, QMS audits, and notified body liaison. I can also provide you with the EU Authorised Representative service. If you need reliability and speed for your medical devices projects, get in touch.