New Technologies & New Products
New Technologies & New Products

Byonoy Absorbance96 Microplate Reader : CE-IVD Device in 2021 !!!

2021-01-06
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REF# ABS MH A 01  : Absorbance 96 Microplate Reader incl. Software & 4 wavelengths, 405, 450, 492, 620; 405, 450, 540, 630 (nm) etc.

We recently obtained the ISO 13485 certification. Along with the certification, we registered our product as an IVD device with the CE-IVD marking. 

ISO 13485 MEDICAL DEVICES

Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.