Etteplan strengthens its role as MedTech development partner

Etteplan Sweden has received certification to the latest medical device quality management standard, ISO 13485:2016, for its management system. The certification makes it easier for customers who want to subcontract their product development to a partner. Etteplan designs and develops medical devices on a contract basis.

ISO 13485 is a quality management standard for medical devices and services. The updated 2016 version has stricter requirements and is conformed to global and European regulatory requirements.

“The certification serves as proof that we can satisfy both customer requirements and regulatory requirements efficiently and systematically, and deliver technology and product development to an industry with exacting standards. It also opens the doors to new, larger assignments from existing and new customers within development-intensive medical device industry, ” says Mikael Vatn, SVP Central & Western Europe at Etteplan.

Etteplan designs and develops MedTech solutions that contain electronics, mechanics and software, such as products to be used for diagnosis, monitoring and treatment.
Some of the many areas in which Etteplan has designed solutions include point-of-care monitoring devices, diagnostics, rehabilitation aids, dental equipment, electromagnetic and imaging equipment, transplant equipment, respiratory devices and surgical instruments.

For more information:

Mikael Vatn
Senior Vice President, Central & Western Europe
Etteplan
Tel. +46 708 81 48 20

Outi Torniainen
Senior Vice President, Communications & Marketing
Etteplan Oyj
Tel. +358 40 512 1375