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ISO 13485 Certificate

What is ISO 13485 ?

The ISO 13485 Medical Devices standard is designed specifically for medical device companies. It has specific requirements for accountability, design controls, records retention, process control, customer feedback and more.

ISO 13485 is an ISO standard, published in 2003, that represents the requirements of a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The result of acquiring ISO 13485 is authorization for CE-identification and permission to sell the high quality medical device in the European Union.

As a certification company, De System brings a wide range of experience to every project. Past work includes training for ISO 13485 Medical Devices requirements, and developing ISO 13485 business management systems.

Some of the key issues addressed by ISO 13485 are

  • Regulatory focus
  • Process approach
  • Focus on “meeting customer requirements
  • Focus on “maintaining the effectiveness of the QMS”
  • Maintenance of procedural documentation
  • Clarification of specific differences between ISO 9001 and ISO 13485

Benefits of ISO 13485

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of your supply chain
  • A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
  • Reduces risk factors via the use of risk management techniques
  • Provides a robust framework for assuring product consistency
  • Engages top management involvement