Revisions have been made to the ISO 14971 regulation: medical devices - application of risk management to medical devices.

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Better Information to Meet Requirements

The revision aims to explain the technical requirements by including more detailed information on the course of action manufactures must take to meet those requirements. It also covers the application of risk management to medical devices.

ISO 14971 and Risk Management helps manufacturers identify and understand hazards and prevent failures associated with medical devices. Risk analysis is key in the development and design of medical devices.

Greenlight Guru Survey

A survey from the “State of Medical Device Product Development & Quality Management Report 2020”, undertaken by Greenlight Guru, showed that 81% of medical device companies are not currently using tools/devices designed for the industry in their quality management processes. 

The “State of Medical Device Product Development & Quality Management Report 2020” was an online survey carried out between September 11th and September 27th, 2019 which consisted of 524 participants.

 “To find that more than 80% of organisations are asking their quality and engineering teams to ‘make do’ with legacy tools and solutions is as an eye-opener. Quality isn’t a department, but a cultural mindset within a business. Quality cannot be treated as a check-the-box activity - unfortunately, even when mandated by law, we’re seeing companies do the bare minimum.” Said David DeRam, CEO of Greenlight Guru. 

EU Regulation

From 26th May 2020, The European Union Medical Device Regulation (MDR) applies to member states of the EU. The requirements in the regulation must be met before a device can be placed on the market, including the general safety and performance of the medical device.

To make devices safer and more effective, materials testing is advised to be routinely carried out to evaluate the potential for metal wear and corrosion of a device, through various tests.  

As an independent UKAS accredited test laboratory, Rotech supports Medical Device manufacturers, who are regulated by stringent quality control requirements. 

Our Cleanliness Testing* laboratory can help determine whether contaminants are present on the material/sample. Therefore, helping to reduce the risk of contamination and infection.

Rotech’s Spark OES and ICP-OES Chemical analysis capabilities, Scanning Electron Microscope (SEM), Microscopical Investigations and Hardness Testing (BS EN 6507-1-2005) allows us to offer an all in one testing service.

Why Rotech?

Customers turn to us for our fast turnaround, trusted and reliable service, and for quality assurance.

Medical devices are commonly made from the following metals and metal alloys: stainless steel, cobalt-chrome alloy, titanium, and nickel-titanium alloy. Gold, platinum, silver, iridium, tantalum, and tungsten are also common in many medical devices.

Within our lab, the Rotech team of metallurgists and technicians have previously tested drills, scalpels, retractors, clamps, syringes, forceps, orthopaedic instruments, as well as beauty industry items such as nail manicure sets and tweezers.

Please refer to our case study, ‘Rotech Investigate Fractured Drill Bit for Specialist Medical Supplier’ for an example of our Medical Device Testing.

The activities identified with * are not UKAS accredited.

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