• MDSS Hannover - Authorized Representative
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No CE marking needed!

On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).

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MDSS Consulting GmbH

Together we bring your medical products to the world market, meet international regulations and guarantee product quality and safety.

Quality Management

The introduction of a quality management system according to EN ISO 13485 often marks the beginning of the world of the medical device industry.

Regulatory Affairs

The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market.

Clinical evaluation

The clinical evaluation is an essential part of the technical documentation and a prerequisite for the fulfilment of the Essential Requirements.

The EU Regulations for medical devices and in-vitro-diagnostics MDR (EU) 2017/745 & IVDR (EU) 2017/746 are casting their shadows. It is time to act!



MDSS Consulting GmbH will analyse  with you your existing documentation and demonstrate to what extent you must become active in order to fulfil the new requirements. Based on a gap analysis we will identify the discrepancies between the actual state within your organization and the target criteria of the legal requirements of the MDR or IVDR - while maintaining your present company policy.

We are happy to accompany you through these challenging regulatory times

MDSS Consulting GmbH

Schiffgraben 41
30175 Hannover
Germany

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