Mediafe ISO 13485:2016 Certificate
Medisafe Certification for Medical Device Quality Management Systems.
Medisafe is ISO 13485:2016 certified, meeting all quality management system parameters specific to medical devices.
What’s the ISO?
The International Organization for Standardization (ISO) is an independent, non-governmental organization with a membership of 167 national standards bodies. It is based in Switzerland and develops voluntary, consensus-based, market relevant worldwide that support innovation and provide solutions to global challenges.
What’s “ISO 13485:2016 certified” mean?
This certification specifically sets out the quality management system parameters specific to medical devices, specifically with respect to risk management, safeguards and quality control in supply chain management. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Why was ISO 13485 recently updated and what are the main improvements?
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
How does this help Medisafe?
See more our ISO 13485:2016 announcement.