ISO 13485 is the internationally recognized standard for quality management in the medical devices industry. KEMA has transformed the ISO 13485 certification process into an opportunity for you to improve your company’s efficiency and increase profits. Additionally, the ISO 13485 certification can open international doors into new markets because   many countries require this ISO 13485 certification.The standard has a lot in common with the requirements of the Medical Directives (AIMDD, MDD, IVDD). As Notified Body, KEMA is able to certify the Quality Management System as well as the product-related aspect in one combined audit. All regulatory auditing for medical devices via one service provider: KEMA.

KEMA is also recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS). KEMA is an accredited body for QSIT inspections for the US market. 

KEMA: All regulatory audits via one service provider!

When your facility is due for a quality system audit, the ISO 13485:2003 enables you to combine the quality system requirements with the regulatory requirements. KEMA’s Notified Body auditor, who is also your contact for the Medical Directives (AIMDD, MDD, IVDD) CE certification, will be the lead auditor.

There are clear advantages for selecting KEMA:

• KEMA is able to certify the Quality Management System as well as the product -related aspect in one combined audit. All regulatory auditing for medical devices via one service provider: KEMA 
• KEMA knows your organization, quality system, and products from CE auditing. 
• CE certification audits and ISO 13485 auditing are integrated, thus saving overall audit time in your facility 
• The regulatory knowledge of the Notified Body auditors will be useful for the ISO 13485:2003 certification. 
• You have the assurance that your certificate has been issued by one of the leading Notified Bodies worldwide. 
• In our unique approach to certification, we customize the process in every possible way, providing a service that meets your individual requirements. With this focus in mind, our auditors uncover ways to benefit you. 
• At KEMA, our primary focus is your success in the context of ISO 13485 conformance. To customize our certification services, we align our audit plan with your business goals. By doing so, we assist you in achieving your management objectives.         

For more information please contact us.