Intertek strengthens its Medical Notified Body function and applies for the Medical Device Regulation in Sweden to support the needs of customers
February 15, 2018
Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical function for the medical device industry in Europe to deliver a superior level of service for its customers. As part of these changes and to ensure a smooth transition for customers, a centre of excellence will be established ahead of the implementation of the update to the European Medical Device Regulation (MDR).
Intertek will transition its European Notified Body Medical activities to Intertek Semko AB (NB No 0413) in Kista, Sweden. Intertek’s UK Notified Body, AMTAC (NB No 0473), will be gradually phased out and eventually closed by 1 July 2018. Relevant resources at AMTAC will also transfer to report into Semko, but remain at current locations.
Intertek submitted its application for the MDR to the Swedish Medical Products Agency in January 2018, affirming the Group’s commitment to this key market and to the ongoing support of its customers during this period of transition.
Nakisa Harmes, Head of Intertek Notified Body Medical said: “The medical sector provides a significant growth opportunity for Intertek, and we are excited about delivering a truly world class service for our customer by strengthening our Notified Body for the medical devices industry in Europe. Centralising and enhancing our team of specialists to create a centre of excellence will also allow us to provide bespoke solutions to our customers from an even stronger base.”
For Media Information
UK Marketing Director
Tel: +44 7799 605719
For Technical Information
Head of Intertek Notified Body Medical
Tel: +46 875 00480
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 42,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.