ISO 13485 Certificate
Medical Devices Quality Management
Certification Overview
ISO 13485:2016 is a standard that defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory requirements, an organisation does not need to be actively manufacturing medical devices or their components to seek certification to this standard. The standard states that ISO 13485 applies to companies “involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support)”. ISO 13485:2016 applies to design, development, production, installation and servicing of medical devices. ISO 13485 Certification is a measure of your ability to meet customer and regulatory requirements.
ISO 13485 Certification Benefits
ISO 13485 Certification will provide your customers with an assurance that your product has been produced under controlled conditions that ensure the medical device or medical device components are fit for purpose before release into the marketplace.
Benefits of ISO 13485 Certification could include:-
- Expand access to more markets worldwide by having an audited and certified management system in place.
- Outline how to review and improve processes across your organisation.
- Increase efficiency, cut costs and monitor supply chain performance.
- ISO 13485 certification helps you improve your products and processes.
- Meet customer and regulatory requirements.
