Member directory

MEDDEV QA

Type of organisation:

Specialism:

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.

Email

medicaldevices@aol.com

Telephone

+44 (0)1446 774948 / +44 (0)7714 288232

Address

5 Hillside Drive,
Cowbridge

Vale of Glamorgan

CF71 7EA

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