LIFE SCIENCES
Life through a lens
Matthew Dale discovers embedded processing and new CMOS technology are bringing advances to medical and life science imaging
T
hree years ago, camera manufacturer Basler recognised the medical and life science market as its second most
important market for imaging aſter factory automation. While historically there has been an overlap
between the cameras used by the factory automation and medical and life science markets, according to Peter Behringer, team leader of Basler’s medical product market management, with features such as high reliability and robustness being valued by both, the requirements of the two markets are quite different. Tis has led to certain aspects in medical and life science imaging that can’t be covered by classical machine vision cameras. From the beginning of 2018, Basler has been
developing its first range of cameras dedicated to the medical and life science market. It has done this by not only equipping the devices with a more suitable range of features for medical and life science applications, but also by getting its quality management system (QMS) certified by the international standard ISO 13485:2016, which defines the requirements for quality control in the design and manufacture of medical devices. With the ISO 13485-compliant Med Ace series, released in March earlier this year, Basler intends to reduce the time and complexity it takes its customers to get a life science product using imaging to market. ‘For medical device manufacturers it is
getting more and more difficult to bring systems to the market, due to the strict rules of legal authorities,’ said Behringer. ‘Typically, they have to go through between a six-month and one-year design end phase, followed by around a year of certification in which they need to perform testing, produce documentation and communicate with legal authorities. By using ISO
Huron Digital Pathology’s whole slide scanners can be used to create digital images of entire slides in less than a minute
A screen capture from a Huron slide scanner
13485-compliant products for the components of their systems, these manufacturers can save time performing internal testing, due to the amount of testing that has already been done at the facilities producing the products.’ In order to be ISO 13485-compliant, a camera
must be produced in a validated production facility, where not only the device itself is tested extensively, but where the tools being used to test it are also tested thoroughly. ‘It’s an ultra-safe production environment,’
22 Imaging and Machine Vision Europe • December 2018/January 2019
Behringer explained. ‘Te ISO 13485 certification also means that customers who purchase these products are notified if a change to the product needs to be made, such as if a new firmware update is needed, or if a component is reaching end-of-life and has to be replaced.’ He added that ISO 13485 is not only
happening in Europe, but also in the US, with the FDA planning to integrate the ISO13485:2016 into its 21 CFR 820 – the quality system regulation for medical devices sold in the United
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Huron Digital Pathology
Huron Digital Pathology
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