Examec is a supplier to some of the most demanding clients within medical technology. Machines that we build are a part of advanced equipment for treatment of cancer in the brain as well as other components for medical technology solutions.
We meet the highest manufacturing requirements for medical technology equipment.
In medical technology, the requirements are particularly high in terms of traceability and processes. Examec provides well established, documented and certified procedures and instructions in its entirety for the purchase process, production process, inspection and delivery. And of course we are certified according to ISO 13485 including among other things:
-
-
-
-
-
-
-
-
- Maintenance of a comprehensive technical file for each manufactured device
- Validation of contamination control processes for sterile medical devices
- Monitoring and measurement for complaint handling and regulatory reporting
- A clear definition of specific skills and experience of quality management personnel, plus verification of ongoing training effectiveness
- Formal processes for obtaining and incorporating production and post-production feedback into risk management programs
- Deep validation of quality management system software
-
-
-
-
-
-
-
Moreover, we are accredited according to ETL, a certification that we meet the high quality and safety standards of North America.
In cooperation with our clients we are very proud of our production capabilities and our precision in quality and delivery.
For more information on Examec and Medical Technology, please contact:
Mats Ohlsson
mats.ohlsson@examec.com
+ 46 417-788 81
