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ISO 13485 – QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND IVD

ISO 13485: 2016 standard is the reference for the management system for companies that develop and implement medical devices and IVD, integrating the most general requirements of ISO 9001 with specific requirements for this industry; it specifies the

“Quality Management Systems Requirements that enable an organization to demonstrate its ability to provide medical devices and related services that meet customer requirements and regulatory requirements.”

In Europe, the regulatory requirements are currently fixed by Directive 93/42/EC for medical devices and Directive 98/79/EC for in vitro diagnostic devices, but new Regulations 2017/745 and 2017/746 will replace the Directives and the transition phase started with their publication in May 2017.

Being compliant with the Regulations is never limited to the ISO 13485 consultancy for  the management system;  the ISO 13485 standard calls for the use of other documents such as:

– ISO 14971 standard for risk management of medical devices and IVD

– GHTF model for the technical documentation of the device

that are used to provide evidence of product-related aspects required for a safe and effective use of the device.

Also, the approach used by Studio tau for ISO 13485 consultancy is largely independent of the regulatory framework; Studio tau’s solutions for the management system remain fully valid even operating in markets where the use of Good Medical Practices (GMP) is mandatory.

This means that the same management system can be used by the company to be in full compliance with both European and USA regulations.