We ensure that our business operates within applicable legal requirements
Regulatory requirements are required by law, are non-negotiable and must be complied with. They ensure that a business operates within the confines of the law.
Elos Medtech Complete Performance™ offering entails an unbroken chain from design to manufacturing, packaging, distribution and logistics. All development and production complies with regulatory requirements and rules throughout the entire chain.
Well documented and certificated in accordance with quality standards
Our quality is well documented and we are certified in accordance with the standards required in the area. We hold environmental certification in accordance with ISO 14001. Our quality is documented through certifications ISO 13485 and EEC/MDD 93/42. In the US, we are registered with the FDA (Food and Drug Administration) and operate in accordance with American standards such as QSR and GMP.
Process validated manufacturing processes
Process validation is an essential part of medical device manufacturing. As an FDA-registered manufacturer of medical devices, we perform process validation for the manufacturing processes that produce all the products and components.
High quality, safety and reliability regardless of demands
We apply the same quality standards to all our medical device products and processes. This means that we maintain the same high quality regardless of application, market or classification. The regulatory requirements ensure that our medical technology products and components are safe to use, clean and sterile, consistent in quality and regularly controlled.
RA/QA competence and experts
In order to further develop our well-known high quality and meet the increasing regulatory requirements, we have RA/QA competence and experts at each subsidiary which we offer through our concept Complete Performance™. We offer high competence based on our long experience and continuous education within medical device to support and guide our customer in the regulatory and quality field, both according to international standards and certifications as well as country specific requirements.
Our clean rooms fulfill
ISO class 7
Registration number at FDA
Elos Medtech Pinol A/S: 3007689689
Elos Medtech Timmersdala AB: 3003847101
Elos Medtech Microplast AB: 3012416874
Onyx Medical LLC: 1043653
Download certificates here:
EC product certificate Elos Medtech Pinol AS issued Dec 19, 2017
ISO 13485 CMDCAS, Elos Medtech Pinol A/S
ISO 13485:2003 Certificate Onyx Medical
ISO 9001 Elos Medtech Pinol A/S issued Nov 13, 20017
Product Certificate Elos Medtech Timmersdala AB issued Nov 15, 2017
ISO 13485 Certificate Elos Medtech AB issued Dec 21, 2017
ISO 14001 Certificate Elos Medtech AB including business centers in Appendix