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20 Jan, 2022

Bioservo has received certification according to ISO 13485

Bioservo Technologies AB has received certification according to ISO13485 from Lloyd´s Register Quality Assurance Limited. The certification is part of a larger investment in medical technology products for people with impaired hand function and sales in a broader international market.

During the year, the launch of Carbonhand 2.0 in Europe is planned, a completely new version of a force-strengthening glove that can be used both as an aid and as an aid in rehabilitation in the event of impaired hand function.

ISO 13485 is an international standard that defines requirements for quality management systems for manufacturers of medical equipment. Carbonhand 2.0 will be classified as a medical device and is thus covered by the European Union Medical Device Regulation (MDR).

The certification obtained is proof that our quality system follows the rules and guidelines required by most national authorities. The US FDA has also previously announced that they will replace QSR with ISO 13485: 2016 shortly, which means that Bioservo's certification according to this standard fits well with the plans to introduce Carbonhand in the US market.

For more information, please contact:
Petter Bäckgren, CEO
petter.backgren@bioservo.com
+46 8 21 17 10

or

Mikael Wester, Marketing Director
Mikael.wester@bioservo.com
+46 8 21 17 10

About Bioservo Technologies
Bioservo Technologies AB (publ) is a world leading company in wearable muscle strengthening systems for people in need of extra strength and endurance. All our innovative products and systems are designed to keep people strong, healthy, and efficient.

The company has a unique global position within soft exoskeleton technology for the hand, both for industrial applications to improve the health for workers and to improve quality of life for people with reduced muscle strength.

Bioservo Technologies was founded in 2006 in collaboration between researchers at the Royal Institute of Technology and a doctor at Karolinska University Hospital. Bioservo Technologies is a Swedish public limited company with headquarters in Stockholm.

FNCA Sweden AB, +46(0)8-52800399, info@fnca.se is the company’s Certified Adviser on Nasdaq First North

For more information, please visit www.bioservo.com