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:

IVD New Regulations CE Marking Workshop -

Thursday 16th January 2020

CE Marking & FDA Regulations Workshop -

Thursday 13 February 2020

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

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