What we do

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 maintain a quality management system certificate in compliance with:

• ISO 13485:2016

All our certificates can be obtained without charge from: quality@swemac.com.

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 assurance or regulatory affairs, please contact:

Quality Assurance and Regulatory Affairs Manager
quality@swemac.com

Products mentioned on this web page may not be approved for use in all countries. Please contact Swemac for information about the regulatory approval status in individual countries. Nothing on this web site should be construed as a solicitation for or promotion of any product or for the use of any product in a way which is not authorized under the laws of the country where the reader is located.

All information on this web site is provided "as is" without any warranty or guarantee of any kind, expressed or implied, including, without limitation, any implied warranties of sale or fitness for any particular purpose. The readers of this web site agree that the access to and use of information on this web site are at their own risk.

The entire contents of this web site are copyright Swemac. All rights reserved.

Any copying, publication, or distribution of any part of this site is strictly prohibited without the prior written consent of Swemac. In addition, the use of Swemac trademarks without the prior written consent of Swemac is prohibited and may be in violation of worldwide copyright law, trademark law, or other applicable laws.

Swemac accepts no responsibility for typographical errors or technically inaccurate information on this web site. Swemac specifically reserves the right to change, delete, or update information without notice at any time. However, Swemac accepts no obligation to update and maintain the accuracy of the information on this web site.

This web site may contain links to other web sites which are not associated with Swemac. Such web sites are not under the control or review of Swemac. Therefore, Swemac is not responsible for any information provided on those web sites and does not guarantee in any way the accuracy of the information provided at those web sites, nor does Swemac recommend any particular product or service contained on those sites.

The Swemac Resource Library (http://download.swemac.com) is the only part of the swemac.com website where Swemac accepts the obligation to update and maintain the accuracy of the provided information. Swemac reserves the right to change or update this information without prior notice. Obsolete documentation is stored in a separate archive and provided for reference only. It is solely the responsibility of the user to obtain the latest version of the technical documentation. Printed technical  documentation can be provided free of charge upon request. Delivery time is max 7 days.