Applicable Standard to Medical Device

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ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.
The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. Some of the additional requirements to ISO 9001 requirements relate to

  • design controls,
  • risk management,
  • environmental controls,
  • special processes (e.g. software validation),
  • traceability, record retention, and
  • regulatory actions (such as vigilance),

ISO 13485: 2003 has been harmonised against the medical device directives.

  • Medical Devices Directive
  • Active Implantable Médical Devises Directive,
  • In Vitro Diagnostic Directive

This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.
Formal certification of quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous, for medical companies which export their products to the global market.

  • In the European Union, the fulfillment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices.
  • Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 by an accredited certification body.

Who Can Go For ISO 13485 Certification?

  • Companies who design, manufacture, distribute, install and service medical devices for the European and World markets.
  • Companies who manufacture OEM products which are sold under other company names.
  • Companies who design and/or manufacture medical device components or raw materials for the medical device market.
  • Companies selling, installing or servicing medical devices.
  • Certification providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.

To Know more on

      1. What is medical device
      2. Scope of certificcation
      3. Activity Plan
Request a Guideline Document ..

ISO 13485 implementation improves / leads to

  • POLICIES & OBJECTIVES set by 'top management'
  • Conformance to Legal and Regulatory Requirements
  • Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization's image, culture and performance.
  • improved internal and external Communications
  • greater understanding of the organization's processes
  • clear responsibilities and authorities agreed for all staff
  • improved use of time and resources
  • reduced wastage
  • greater consistency and traceability of products and services
  • Customer Confidence, Satisfaction and TRUST
  • Level of Assurance in Organisational QUALITY
  • Organisational PROFITABILITY
  • Ability to Differentiate Organisation for Competitive Advantage
  • Organisational Credibility & Reputation

We offer a customized training programme on ISO 13485:2003 for

Next Applicable Standard:  ISO 13485
Other Applicable Standards
ISO 9001, ISO/TS 16949, ISO 13485, AS 9100.

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