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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.

Consult the detailed specifications of the Fit 4 Innovation – Health Tech Market programme

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

Key figures

  • 8 weeks analysis the company project/product and identification of the impact of medical regulations
  • 1 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

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 consultants

Become a Fit 4 Innovation – Health Tech Market consultant

Applications are open until 15 November 2022.

The Call for consultants is open to independent consultants as well as to consulting firms.

Applications must be sent to Luxinnovation by email: fit4innovationhealthtech@luxinnovation.lu.

Applications must include the following information:

  • A copy of the articles of association of consulting firms or a proof of the legal status of independent consultants
  • Bank details
  • Balance sheet and profit and loss accounts for the last financial year
  • A Curriculum Vitae of independent consultants or of all consultants of a company who are likely to work in the context of the Fit 4 Innovation – Health Tech Market market programme, including a presentation of their skills and experience
  • A track record of consulting in supporting medical device CE marking of the last 3 years (including related earnings)
  • A cover letter explaining applicants’ interest in the programme as well as information about their availability for the programme, their availability to travel and their spoken languages.

For additional information, please refer to the detailed specifications of the Call for Fit 4 Innovation – Health Tech Market consultants

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