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.” 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.