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ISO 13485 Medical Devices

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

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ISO 13485:2003 is the latest version of ISO 13485, published in July 2003.  This standard is based on the ISO 9001:2000 process model approach.

 

We are formally recognized under the regulatory systems of Europe and Canada and are committed to seeking formal recognition under the USA and Japanese regulatory systems as they evolve and the opportunities arise.

 

Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device regulations around the world.

1. Gap Analysis & Planning:

 

  • Ensure you have the commitment of top management.
  • Define, with the authorization of top management, your company's medical devices.
  • Planning must be completed to establish a framework for identifying hazards, risk assessments and the implementation of necessary control measures.
  • Legal obligations must be identified and understood, objectives set and a management programme for achieving them implemented; this entire process should be documented.

2. Implementation of ISO 13485:

  • Introducing performance, measuring and monitoring practices.
  • Establishing and documenting responsibility and authority for accidents, incidents, non-conformities, and corrective and preventative action.
  • Establishing a procedure for records and records management.
  • Auditing and assessing the performance of the management system.
  • Performing management reviews of the system at identified and defined intervals.

3. Internal Audit Process

4. Certification Audit Process

This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard.  With ISO 13485 certification you will be able to enter any major market around the world with one audit!
By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.

 

​By becoming certified in the ISO 13485 standard your company will:

 

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations​
  • Help monitor the effectiveness of your supply chain
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements
Overview
Benefits
Steps to certification
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