What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
Who is ISO13485 for?
ISO 13485 is designed to be used by organisations 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.
Certification/Registration to ISO13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organisations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard.
Why was ISO13485 revised 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.
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