James Hamerslag reflects on his long tenure at Siemens Healthineers, the evolution of packaging and automation in medical ...

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations.

Medical devices comprise electronic equipment; implants; consumables and disposables; surgical instruments and in-vitro diagnostic reagents among others. Testing at government labs is free of cost.

to In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR). Historically, IVD devices could be self-assessed under the 1998 Directive, meaning that manufacturers could declare that the device was ...

This article presents a set of in vitro assay methods for evaluating ... and inform site visitors interested in medical research, science, medical devices and treatments.

The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional ...

Archimed has bought BioVendor, with plans to build and internationalize the Czech diagnostics company. Archimed sees ...

Our Bureau, New Delhi Friday, March 21, 2025, 08:00 Hrs [IST] ...

is proud to announce that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic Medical Devices ...

This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the ...

The global Medical Device Contract Manufacturing market size was $73.61 billion in 2023 and is projected to reach $81.19 billion in 2024. This market is expected to grow significantly, reaching ...