Quality First International

QFI offers assistance to medical device companies affected by LRQA’s cessation of Notified Body services under the Medical Devices Directives

London-based medical device regulatory consultancy Quality First International offers medical device manufacturers support on this matter, including transitions to another Notified Body.

London, 19 June 2019

The British medical device regulatory consultancy Quality First International advises several client companies affected by the imminent cessation of LRQA’s services as a Notified Body under the current Medical Devices Directives.

QFI has a team in place to help any company requiring support on this matter, including transfers and transitions to another Notified Body for the Medical Devices Directive (93/42/EEC) and the In-Vitro Diagnostic Directive (98/79/EC), facilitating transfer, aligning CE technical documentation expectations to minimise any risk of disruption to business, and agreeing expedition.

Affected medical device companies were informed by LRQA that any current CE certificates will be withdrawn 90 days from the official date of cessation of LRQA’s services.

Medical device manufacturers interested in this service may contact QFI by email enquiries@qualityfirstint.com or telephone +44 (0)208 221 2361.

About Quality First International (QFI)

QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI examines technical documentation, including evidence on expressed and implied warranties (product claims) according to relevant UK laws such as the Trade Descriptions Act and other consumer protection legislation, advises areas requiring attention, for example, applicable designated standards and UK guidance, safety and performance requirement and expected documented QMS procedures. Where requested, QFI can offer in-depth training on UK medical and related legislation to the medical device sector under the QFI College Programme.

For further information please contact:
Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com, Website: www.qualityfirstint.com.