MEDDEV QA Ltd

Product development planning; initial quality and regulatory gap assessments and pre-assessment audits; part-time quality management services; quality systems and capa training; implementation and upgrading of quality systems for iso 9001, iso 13485, fda 21 cfr 820 and the eu medical device directives; device classification queries; preparation of technical files and design dossiers for ce marking; liaison with regulatory bodies; field safety corrective action management, ec vigilance reporting and fda mdr reporting; liaison with notified bodies and other regulatory bodies; internal auditing and vendor quality system auditing; ongoing qa/ra support; eu authorized representative services for non-eu based operations.

MEDDEV QA Ltd Specialism  

Specialism

 

Professional Services

MEDDEV QA Ltd Email  

Email

 

medicaldevices@aol.com

MEDDEV QA Ltd Telephone  

Tel

 

01446 774948 / 07714 288232

MEDDEV QA Ltd Address  

Address

 

5 Hillside Drive,
Cowbridge,
Vale of Glamorgan,
CF71 7EA

Sponsors:

Supprted by Welsh Government