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.
Product certificates for own products according to EEC/MDD 93/42
MDSAP – Elos Medtech Denmark
Our cleanrooms fulfill
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 October 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 703575 Elos Medtech Gørløse issued Oct 17, 2019
Japanese Foreign Manufacturing Certificate, Elos Medtech Gorlose
Are you ready to get started?
We provide some of the biggest medtech companies in the world with contract manufacturing and development solutions. Let us become your trusted solution partner too.