Committed to product performance and excellence

To ensure compliance for our own products, support our customers, and meet the increasing regulatory requirements, we have RA/QA competence and experts within our company, which is offered through our value-adding concept Complete Performance™.

High competence in medical device standards and regulations

We offer high competence based on long experience and continuous education in medical device standards and regulations to support and guide our customers in the regulatory world, both according to international standards as well as country-specific jurisdictions.

Certificates

ISO 13485:2016
ISO 14001:2015
Product certificates for own products according to EEC/MDD 93/42
MDSAP – Elos Medtech Denmark

Our cleanrooms fulfill

ISO 14644-1

Registration number at FDA

Elos Medtech Pinol A/S: 3007689689
Elos Medtech Timmersdala AB: 3003847101
Elos Medtech Skara AB: 3012416874
Elos Medtech Onyx LLC: 1043653

Download certificates here:
EC product certificate Elos Medtech Gørløse issued Feb 12 2019
ISO 13485 Cert Elos Medtech Memphis issued June 2021
ISO 9001 Elos Medtech Gørløse issued April 20121
ISO 13485 Certificate Elos Medtech AB issued April 12, 2021
ISO 14001 Certificate Elos medtech AB including business centers in Appendix
Japanese Foreign Manufacturing Certificate, Onyx Medical LLC
MDSAP Elos Medtech Gørløse issued Oct 17, 2019