The regulations for medical devices in the United States require the Food and Drug Administration (FDA) to inspect your facility at regular intervals. KEMA can do this for you on behalf of the FDA. KEMA is an accredited body for eligible QSIT inspections.

KEMA is also a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS) and for the internationally recognized standard: ISO 13485.  

KEMA: All regulatory audits via one service provider!

When your facility is due for a quality system audit, the FDA Third-Party Audit enables you to combine the quality system requirements with the regulatory requirements. KEMA is also your contact for the Medical Directives (AIMDD, MDD, IVDD) CE certification.

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 FDA Third-Party Audits are integrated, thus saving overall audit time in your facility 
• The regulatory knowledge of the Notified Body auditors will be useful for the FDA Third-Party Audit 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 FDA third-party 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.