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Home > Certification > Products >Medical Devices

Medical Devices

Production of medical devices is a strictly regulated business. These products can be crucial in matters of life and death. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance. ​
 
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Purpose

Certification to the quality management system standards and directives applicable to this industry works to ensure that only safe and reliable medical equipment is available on the market. 

Benefits

Certification here is a ticket-to-trade. To be able to access markets in the European Union (EU) and certain other countries, you are required to comply with applicable directives and quality management system standards. When partnering with DNV Business Assurance for your certification, we work with you to ensure an efficient and reliable certification process.​
ISO 13485 ​An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs. MDD - The Medical Devices Directive ​The Medical Devices Directive 93/42/EEC defines safety and reliability requirements for medical equipment to be sold in the EEC. The requirements apply to both products and manufacturers.