Ensuring confidence in medical device safety

   The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. Whatever devices organization's produce, as medical device manufacturer/s, they have the responsibility to consistently deliver devices that are safe and effective. ISO 13485 is the international standard recognized for medical device regulations around the world.

In the field of medical products, devices and components, regulatory requirements and customer needs regarding quality are becoming ever-more stringent. Legal manufacturers and their global suppliers are expected to pro-actively comply with the highest standards and regulations. Certification is needed before entering new markets or before customers place orders. ISO 13485 is now the foundation for all regulatory requirements.

Gaining certification to ISO 13485 will help organization do business in this highly regulated sector. Whether organization's are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help demonstrate to customers and regulators that they are committed to quality.

The regular assessment process will ensure that processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification to this standard can improve overall performance, remove uncertainty and widen market opportunities with complying to requirements, such as Basic Quality System requirements with several enhancements

Risk Management Approach to product development and product realization    
Validation of processes      
Consideration of statutory and regulatory requirements      
Tracking and record keeping      
Assuring positive product trace ability and recall

Who is it relevant to?

ISO 13485 is relevant to all manufacturers of medical devices (including subcontract manufacturers) to satisfy both regulatory and voluntary requirements.


  • ISO 13485 or in combination with regulatory certification, will be viewed by organization's customers, distributors and authorities as a genuine commitment to the quality of medical devices during the approval or bidding process.
  • Most medical device manufacturers will eventually want to sell their products worldwide. Certification to this standard will help achieve this objective.
  • Regular assessments performed by Zenith will help organization's to monitor and improve their management system and processes. This improves the reliability of operations and products, ensures compliance with regulatory and customer requirements and increases financial performance.