CE Marking - MDR/IVDR

FDA

Technical Files

Quality

(ISO 13485/21CFR820)

Clinical Strategy and Evaluation

Training

Internal Audits

Person Responsible for Regulatory Compliance

Global Regulatory Requirements

Taking medical technology ventures to market worldwide

Upcoming events, in partnership with SEHTA:

SEHTA 2020 International MedTech Expo & Conference
Devices, Diagnostics, Digital -

Thursday 26 March 2020

Software/AI Medical Device EU MDR CE Marking Workshop - 31 March 2020

EU Medical Device & InVitro Diagnostic CE Marking Workshop - 28 April 2020

MDR/IVDR Technical File / Risk Management / QMS Workshop - 21 May 2020

Psephos Biomedica works with clients from around the world to bring medical technologies to market.

We are a highly focused, experienced team that takes on a limited number of clients thus ensuring they get the best of us.

Our Services

MEDICAL DEVICE

STRATEGY

MEDICAL DEVICE REGULATION

MEDICAL DEVICE CLINICAL EVALUATION

Discover more about our professional services

Clients

We've worked closely with some of the medical world's most innovative companies across Europe, North and South America, Middle East, Africa and Asia.

Psephos Biomedica Client Apica Cardiovascular

Psephos Biomedica Client BD

Psephos Biomedica Client Claret Medical

Psephos Biomedica Client Conor Medsystems

Psephos Biomedica Client Lifecare Medical Devices

Psephos Biomedica Client Lightpoint Medical

Psephos Biomedica Client Merlin MD

Psephos Biomedica Client Novella Clinical

Psephos Biomedica Client Plessey