CONSULTING SERVICES

Welcome to Quality First International
a medical devices consultancy

Quality First International is a leading, global medical devices consultancy, with extensive insight and business know-how in the medical devices regulatory field. QFI is committed to solving your regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace. With our technical expertise, accuracy and confidentiality we can help you be the first to market, reinforce the approval of your medical device, resolve any compliance issues and solve other problems encountered during the regulatory approval of your medical device.

Latest News...

Deadline for registration of medical devices in Italy has been postponed from 30 April 2009 to 31 December 2009 (1 May 2009)

Deadline for re-registration of medical devices and IVDs in the UK is 31 May 2009 (17 April 2009)

Download a FREE white paper comparing the Medical Device Directive and the Toys Directive (27 March 2009)

Download a FREE white paper on the transposition of Amending Directive 2007/47/EC (16 February 2009)

All product technical documentation for marketed medical devices must be revised by March 2010 to comply with Directive 2007/47/EC – One year left (28 January 2009)

Extended Deadline for Registration of Medical Devices in Italy (19 January 2009)

Regulatory Alert: Call For Submission of EC Classification Problems Relating to Medical Devices (16 December 2008)

Regulatory Alert: Imprecise Interpretation of Clinical Data Requirements Continues to Cause Regulatory Problems in Europe (10 December 2008)

Regulatory Alert: New Challenges in Clinical Data Evaluation for Medical Device Manufacturers Following Amendment of the Medical Devices Directive (30 October 2008)

MANDATORY REGISTRATION OF CLASS I, IIa, IIb AND III MEDICAL DEVICES in ITALY – Quality First International alerts clients and medtech companies (10 October 2008)