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Newsletter Medical - Health

Medical - Health

In a sector characterised by abundant regulatory news, an increasingly connected medical environment and growing internationalisation, LNE's Medical-Health Newsletter aims to shed light on recent regulatory developments, to present its services and to share expert opinions with you.

European regulations 2017/745 and 2017/746

The practical steps of rolling out European regulations on medical devices 2017/745 (MD) and 2017/746 (IVD MD) have started and the various actors ...

Compliance assessment campaign for electromedical devices

For more than 20 years, Olivier Monaque has been supporting the manufacturers of medical devices (MD) in assessing compliance of their devices and ...

Demonstration of clinical evidence of in IVD MD

Regulation 2017/746 on in vitro diagnostic medical devices considerably strengthens certain key aspects of the current regulatory approach. New ...

Software for IVD-MD in Regulation (EU) 2017/746

Directive 98/79/EC on in vitro diagnostic medical devices (IVD-MD) will soon be 20 years old. Since its publication, computer data processing has ...

LNE strengthens its activities in the field of cardiovascular diseases

LNE has long invested in improving the reliability of biomarker assays and, through its work, participation in research projects, accreditations and ...
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