ISO 13485 MEDICAL DEVICE

ISO 13485: 2016 Medical Device is the quality management system standard specifically developed for medical devices.  Organizations looking to expand their market to Europe, Canada, and other nations require the implementation of the ISO 13485 quality management system.  ISO 13485 Certification is a requirement for CE Marking.

In the United States, the Food and Drug Administration (FDA) has its own regulatory requirements specified in 21 CFR Part 820. Under this regulation, organizations used to design, manufacture, package, label, store, install or serve any medical device for human use are required to develop and implement US FDA Medical device GMP (Good Manufacturing Practice) standards and procedures for achieving US FDA Medical device GMP. The US FDA Medical Device GMP and ISO 13485 are more or less the same and the implementation of one system can help you achieve the other.

BENEFITS OF ISO 13485 MEDICAL DEVICE CERTIFICATION

ISO 13485 Medical Device

When implementing ISO 13485 standards, organizations adopt a risk-based approach to each and every process that affects the quality of their products. ISO 13485 is an international quality certification that enables organizations to establish the QMS in all phases of their product realization including design and development, production, installation, and post-market surveillance. Ultimately, they have a better control over their processes and there is continual improvement possible in all areas of the organization.

  • Increase Credibility of your organization
  • Enhance Business Performance and customer satisfaction
  • Demonstrate Commitment to High-Quality by Managing quality throughout the life-cycle of a medical device
  • Continuous improvement of the product realization processes of medical devices
  • Ensures safety in medical devices and continuous improvement of the devices
  • Participate in international and foreign government tenders
  • Achieving compliance with European regulatory requirements
  • A requirement of CE mark and for the permission to sell medical devices in the European Union

INTEGRATING ISO 13485 MEDICAL DEVICE, ISO 9001, AND GMP

Integrating multiple quality management systems has many advantages.

  • For example, a medical device company may choose to implement ISO 9001, US FDA medical device GMP (21 CFR 820) and ISO 13485 standards together if they are seeking to do business in various global markets like the US, Europe and other parts of the world.
  • It helps you avoid developing and maintaining multiple lists of quality management system documents.
  • By choosing a European notification body for ISO 13485 Certification, It allows you save time and money. (Choosing the same registrar (certification body) for ISO 13485 Certification and CE Marking will help you avoid two separate audits).

We have associates and offices around the world and our consultants are knowledgeable about various markets. They can help you with developing the system, which includes: Quality manual, Quality system procedures, Quality system implementation, Internal audit, Certification body selection, and Audit support.

Our ISO 13485 Certification process includes:

  • Understanding your existing Quality Management System related to ISO 9001 requirements (GAP analysis)
  • Developing documents such as quality manual, procedures, forms, templates.
  • ISO awareness training (Providing the required training for the QMS team)
  • Review of your Standard Operating Procedures (SOP)
  • Implementing a well-documented Quality Management System throughout your organization.
  • Internal Audit identifying non-conformities related to ISO 9001 requirements.
  • Management Review Meetings
  • Corrective and preventive actions /Root cause analysis addressing non-conformities. (CAPA)
  • Certification body (Registrar) selection
  • Certification body (Registrar) audit support
  • Closing of any non-conformities Identified by the certification/notification body
  • Issuance of ISO 13485 Certification.
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