ISO 13485

ISO 13485:2003 Certification Ensure confidence in medical device safety. 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 traceability and recall

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

Benefits :

·       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.