Swemac is committed to ensuring that all our products and services meet the highest levels of quality, safety and efficacy.

Swemac has extensive experience from the development of orthopaedic implants and instruments for trauma and joint surgery. In close cooperation with customers and university hospitals, Swemac has developed a wide range of market leading medical devices. Swemac designs, manufactures and delivers products that provide the optimal therapeutic benefit for patients. Our products are safe, effective and reliable for their intended purposes and comply with all applicable requirements and regulations.

Our Quality Management System helps us maintain an effective quality program for all aspects of our business, in order to provide products and services that meet and exceed our customers’ requirements and to maintain a high level of compliance with regulations and international standards. We take pride in our quality assurance and work closely with our suppliers and distributors to ensure that they fulfill the highest quality standards. 

Swemac holds an EC Certificate for full quality assurance in compliance with:

  • Medical Device Directive (MDD 93/42/EEC), Annex II

We also hold several quality management system certificates that are regularly updated:

  • EN-ISO 13485:2012

All our certificates can be obtained without charge from: This email address is being protected from spambots. You need JavaScript enabled to view it. .

In addition to our internal audit programs, our Notified Body, Intertek Certification Sweden, annually conducts independent audits of all our sites and of our head office in Linköping, Sweden.

If you have any questions regarding Swemac quality work please contact:

Quality Assurance and Regulatory Affairs Manager
This email address is being protected from spambots. You need JavaScript enabled to view it.

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ISO-13485-2012-black-TM

© Swemac 2017 | SE-583 35 Linköping, Sweden | Phone +46 13 37 40 30 | Fax +46 13 14 00 26 | This email address is being protected from spambots. You need JavaScript enabled to view it. | More contact information >>