VTT Expert Services Oy and Nemko AS to co-operate in CB scheme within the medical device sector

VTT Expert Services Oy (Finland) and Nemko AS (Norway) announce co-operation within the international IECEE/CB-scheme regarding testing of medical devices, taking effect within six months from today (3 October 2011).

As a result of this co-operation VTT Expert Services Oy will continue providing CB Test Laboratory (CBTL) services to its medical device customers as before. Nemko AS will as the certification body (NCB) provide the CB Test Certificates to those customers.

In addition to the described CB activities, both parties will continue providing their testing and certification services as before. However, the existing and new customers will be able to benefit from the co-operation as a complementary service offering from VTT Expert Services Oy and Nemko Oy, Finland, as follows:

The services to medical device sector at VTT Expert Services Oy cover

• Safety testing
• Mechanical testing
• Environmental testing
• Risk management file assessment
• Software safety assessment
• Pre-review services regarding the above
• Training regarding the above

The services to medical device sector at Nemko Oy cover

• EMC testing
• Telecom testing
• Safety testing
• Mechanical testing
• Environmental testing
• Pre-review services regarding the above
• Training regarding the above

In addition Nemko offers assistance with market access for a number of countries worldwide.

Both VTT Expert Services Oy and Nemko AS will continue to be independent providers of

• Notified Body services regarding CE-marking of medical devices and
• Quality management system certification (including ISO 13485).

The parties have an understanding to further develop their market access services for the benefit of the manufacturers in the medical device sector.

Additional information
Nemko Oy, Arto Konttinen, CEO, Tel +358 424 5454 315
Nemko Oy, Tomi Nyberg, Business Development Director, Tel +358 400 534 284

VTT Expert Services Oy, Matti Lanu, Vice President, Services, Tel +358 20 722 6935
VTT Expert Services Oy, Antti Turtola, Customer Relations Manager, Tel +358 20 722 5639

VTT Expert Services Oy
VTT Expert Services Oy supports its clients in the development of products, services and processes and their subsequent market launch, as well as during maintenance. We offer versatile expert services, testing, certification and approval services, inspections, analyses and calibration services. VTT Expert Services Oy is part of the VTT Group and operates with 250 professionals in four locations.
www.vttexpertservices.fi

Nemko Group
The Nemko Group is the organization of the independent self-owned foundation NEMKO of Norway, and offers testing, inspection and certification services worldwide, mainly concerning products and systems, but also for machinery, installations and personnel. The Nemko head office is in Oslo, Norway. Own subsidiaries are also established in Germany, Italy, Finland, Sweden, USA, Canada, Korea, Japan, China Mainland, Hong Kong and Taiwan as well as partnerships in UK, France, Spain, Portugal and the Middle East. For quality system certification, Nemko is also present in Uganda, Africa. More than 500 highly qualified people are presently employed in the Nemko Group.
www.nemko.com