Etteplan strengthens its role as MedTech development partnerBack to Releases
- Receives ISO 13485:2016 certification
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:
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Etteplan in brief
Etteplan provides industrial equipment and facility engineering, embedded systems, IoT (Internet of Things), and technical documentation solutions to the world’s leading companies in the manufacturing industry. Our services are geared to improve the competitiveness of our customers' products and engineering processes throughout the product life cycle. The results of Etteplan’s innovative engineering can be seen in numerous industrial solutions and everyday products.
In 2016, Etteplan had a turnover of EUR 183.9 million. The company currently has more than 2,800 professionals in Finland, Sweden, the Netherlands, Germany, Poland and China. Etteplan's shares are listed on Nasdaq Helsinki Ltd under the ETTE ticker. www.etteplan.com