Le Gouvernement du Grand-Duché du Luxembourg

Help companies accelerate the market access for their health technologies

Become a Fit 4 Innovation – Health Tech Market consultant

We are looking for experienced, specialised consultants who can help companies define their regulatory roadmap to obtain CE marking for their new and innovative medical devices and thus accelerate their launch on the European market.

Do you have expertise in the field of medical device regulations?

The Fit 4 Innovation – Health Tech Market programme is aimed at helping Luxembourg SMEs to better understand the complex regulatory compliance process that applies to their new and innovative medical devices and obtain the CE marking, mandatory for their introduction on the European market.

As a Fit 4 Innovation – Health Tech Market consultant, you will conduct detailed analyses of the medical devices of selected companies, produce tailor-made action plans with recommendations including cost estimates of how they can comply with European regulations, and support them during the implementation of their action plans.

The consultants are paid by the companies, which are subsidised by the Ministry of the Economy.

Key figures

weeks of analysis

of each company project/product and identification of the impact of medical regulations

action plan

with recommendations to comply with European regulations

Up to 12

months of support

to implement the recommendations

Up to 50%

of co-funding

for companies

Key benefits

Eligible Fit 4 Innovation – Health Tech Market consultants have to be pre-approved by Luxinnovation.

Exposure as an expert in your field
Access to a potential new customer base
Participation in a structured programme managed by Luxinnovation
Co-funding for companies provided by the Ministry of the Economy

Your skills

Consultants must have strong expertise in all or some of the following areas:

Medical device (EU 2017/745) and/or in-vitro diagnostic medical devices (EU 2017/746) regulations
Digital technologies regulations: EU 2016/679 (GDPR), EU 2019/881 (Cybersecurity Act)
Technical standards: Quality Management System (ISO 13485), Good clinical practice (ISO 14155), Medical software (IEC 62304), Medical electrical equipment (IEC 60601 series), labelling and packaging (ISO 11607 series), etc.
Ethical and scientific quality standards relative to clinical studies

Consultant must also have a strong track-record in the CE marking certification process, including experience in some of the following activities:

Conformity establishment (QMS establishment, post-market surveillance, etc.)
Preparation of the technical documentations (e.g. device specifications, risk analysis, etc.)
Language skills: English, French, Luxembourgish or German

Call for Fit 4 Innovation – Health Tech Market consultants

Express your interest to become a Fit 4 Innovation - Health Tech Market consultant

Become a consultant

Become a Fit 4 Innovation – Health Tech Market consultant

Do you have expertise in the field of medical device regulations?

Key figures

Key benefits

Your skills

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