The medical device industry faces specific challenges when bringing their products to the global market.
Medical devices are subject to strict and complex global regulations. Since medical devices are subject to risk, every organization in the supply chain is required to maintain an adequate quality management system. Intertek’s medical device auditing and certification services will provide you with our third-party systems verification carried out by our industry experts.
Intertek is a leading Total Quality Assurance provider of assurance, inspection, testing, certification services for the medical industry. Our unique combination of in-depth knowledge and global presence has brought confidence and peace of mind to thousands of organizations all over the world.
Intertek’s medical devices auditing and certification services include
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NOTICE
Intertek Semko AB, NB 0413, have been made aware of a number of manufacturers selling medical surgical/face masks falsely claiming to be certified by Intertek. Intertek have seen false ‘certificates’ on letterheads, or the use of Intertek’s logo and/or name and Notified body number 0413, as the basis for CE marking against the Medical Device Directive or Personal Protective Equipment Directive. These false ‘certificates’ have no legal value and cannot be used as proof of conformity assessment.
In case of doubt, we recommend that you verify the authenticity of the certificate by contacting Intertek’s Medtech team at medtechsweden@intertek.com. We will review the certificate and respond to your request as soon as possible. We are continuously monitoring these false certificates and reporting them accordingly to the Competent Authorities.
Complaints Handling Process
Information on the Intertek Business Assurance Complaint Handling Process can be found on the GOP-216-INFO document.
Work with Intertek
Intertek is hiring technical staff and auditors globally. If you are interested, please submit your resume with a cover letter.
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