MedTech Market Readiness: Integrated Regulatory Compliance & Investor-Grade Clinical Strategy

Service description

This service provides a comprehensive Regulatory & Clinical Strategy Roadmap designed specifically for HealthTech startups targeting the European market. Unlike standard compliance support, we integrate EU MDR/IVDR requirements with your commercial milestones to ensure investor readiness. Key Deliverables: Regulatory Gap Analysis & Classification Report: A clear assessment of your device under MDR 2017/745 or IVDR 2017/746. Clinical Evaluation Strategy: A step-by-step plan for generating the clinical evidence required for CE marking and reimbursement. Technical Documentation Structuring: Guidance on building a compliant Technical File ready for Notified Body submission. Investor-Ready Risk Assessment: Identifying regulatory risks that could impact valuation and fundraising. This service bridges the gap between technical compliance and business growth, reducing your time-to-market and de-risking your path to Series A/B funding.

Sector

Biotechnology

Digital and Information communication technology

Education and training

Health and medical care

Technology Readiness Level

TRL 1 – Basic principles observed

TRL 2 – Technology concept formulated

TRL 3 – Experimental proof of concept

TRL 4 – Technology validated in lab

TRL 5 – Technology validated in relevant environment

TRL 6 – Technology demonstrated in relevant environment

TRL 7 – System prototype demonstration in operational environment

TRL 8 – System complete and qualified

TRL 9 – Actual system proven in operational environment

Financial requirements

Service Cost & Conditions: This service is offered at commercial rates and is fully eligible for the EIC ACCESS+ 50% co-funding scheme. Daily Rate: €1,250 (Blended Senior Consultant Rate). Project Scope: Typical engagements range from €15,000 to €50,000 depending on TRL and deliverables (e.g., Gap Analysis vs. Full Technical Documentation). Payment Terms: 50% upfront to commence work 50% upon final delivery. Exclusions: Rates exclude VAT and third-party official fees (e.g., Notified Body fees), which remain the beneficiary's responsibility.

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Service

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Service ID

What is the challenge you want to overcome with this service?

In maximum 150 words. Please describe your needs focusing on the current challenges you are experiencing to advance your solution. This information is relevant for the EIC Partner to have a deeper understanding of your challenges and possible solutions.

How do you expect this service to help you address the needs and challenges you have identified?

Please include the deliverables you are aiming to achieve or seeking for.

In maximum 150 words.

Please add any comments or suggestions tailored to your needs that you want the EIC Partner to take into consideration through this service.

In maximum 150 words.

Please describe any questions or uncertainties you may have regarding the service description.

In maximum 150 words.

At which Technology Readiness Level is your innovation or solution?

When filling out the justification, please describe the proof you have for the TRL.

Please give justification about the TRL

At which Business Readiness Level is your innovation or solution?

When filling out the justification, please describe the proof you have for the BRL.

Please give justification about the BRL

Do you have authority or ownership of your solution to disclose information to a third party, e.g., the EIC Partner?

If other, please explain the conditions:

Why did you select this service?

If other, please explain:

If other, please explain why you need this service:

Can you offer equity in return for the service provision?

If other, please explain what you can offer:

How much fund is needed to be raised

What is the funding needed for:

Please explain what are your actual financial needs and for what purpose you intend to use the funds raised?

Please describe your traction providing information on clients and sale.

Have you ever fundraised before?

Why do you need this strategy?

How do you want to develop the strategy: from scratch, rehash an existing strategy, etc.

Type of support needed

Type of support

If other, please explain why you need this service

What is the ideal profile of the partner, investor or customer that you are looking for?

In maximum 100 words.

Type of support (e.g., strategic, technical, financial)

Type of partners (type of organisations)

Sectoral domain of the partner

Purpose for the partnership

Please explain what are your needs for the team

Type of support (Business modelling)

Type of support (Business Plan development, go-to-market strategy, financial forecasts, softlanding programme)

Type of support (Market research)

Type of strategy (business planing, business modelling, marketing, sales, etc.)

Which is the target market?

Why do you need this strategy?

How do you want to develop the strategy: from scratch, rehash an existing strategy, etc.

If other, please explain why you need this service:

Why do you need this service?

I need to develop new business development strategies for my solution or startup

I want to get technical and skill support

I want to get information and knowledge

Other

I am unsure of my specific needs right now and am looking for guidance on how to identify them Please select at least one option.

Please specify the format you prefer (Online, in person, hybrid)

Type of strategy (business planing, business modelling, marketing, sales, etc.)

Briefly describe the areas in which you feel you need the most support in? (Try to be as specific as possible to help us with Coach and/or Mentor matching)

Briefly describe the areas in which you feel you need the most support in? (Try to be as specific as possible to help us with Mentor and/or Coach matching)

Which format and topic do you prefer to receive this service?

Group training, mentoring or coaching on a specific topic

1-1 training, mentoring or coaching on a specific topic

P2P

I am unsure of the best format for me and would like some guidance on coaching methods

Other

If in person or hybrid, please specify where you are able to access the facilities (Country)

Please specify the topic you are interested in

Please specify the format you prefer (Online, in person, hybrid)

Please specify the format you want from the counterpart in P2P exercise

If other, please specify the topic and format: If in person or hybrid, please specify where you are able to access the facilities (Country)

What are your specific needs for your team in respect to coaching, training and mentoring?

Please explain if you are intending to incorporate a new team.

If other, please explain why you need this service:

Why do you need this service to access infrastructure and support R&D?

I need to get technical support for product or service development

I need to get access to technological or technical laboratories / equipment / testbeds

I need co-working spaces

I need access to R&D support funds and opportunities

I need access to technical expertise

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service you have

Please specify which equipment / tools you need

Please describe the type of trials, testing, experiments or other scientific activities you need to conduct

Please specify how you are able to access the facilities (Online, In person, Hybrid)

If in person or hybrid, please specify where you are able to access the facilities (Country)

If other, please explain why you need this service:

Why do you need this IP & Legal service?

I need to get general information on IP or on regulatory aspects

I need to develop a strategy for my IP

I need to develop a strategy for regulatory compliance in a different market

I need to get information and guidance to apply protection for IP

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please describe the market you are targeting:

If other, please specify why you need this service:

What type of due diligence service are you looking for?

Investment readiness

Legal

Environmental

Technological

I need technical support for product or service valuation

I need information on how and where to conduct valuation

I need assessment of technology readiness or market readiness of my product / technology / service

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service you have and the expected results of your solution

If other, please specify what type of due diligence service you are looking for:

Why do you need this Prototyping & PoC service?

I need technical support for prototyping of product or service development

I need access to living labs or fablabs

I need access to expert guidance for prototyping

I need support in the Development of PoC

Support for validation of the prototype or PoC with end users

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service:

Please specify the type of support or facilities you need

Please specify the type of activities you need to conduct

Please specify how you are able to access the service (Online, in person, hybrid)

If hybrid or in person, please specify where you are able to access the facilities (Country)

If other, please explain why you need this service:

What type of service are you looking for?

For recruiting talent

For recruiting C-level professionals

For developing a long-term HR strategy

To access databases for recruiting talent

To access network or platforms to be used as sources of talent

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

If other, please specify what type of service you are looking for:

Please specify (HR and Talent)

What are the functions of the talent you are looking for?

Human Resources

Administrative

Financial experts

Laboratory technicians

I need multiple functions

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

If other, please specify what are the functions of the talent you are looking for:

Which are your target markets/countries for internationlisation?

Are you currently in the process of expanding or internationalising to foreign market or countries?

If yes, please name the market or country

What type of internationalisation support are you seeking?

Expansion and investment readiness assessment

Market Entry Strategy

Sales and marketing support

Fundrasing and commercialisation support

Distribution support

Matchmaking and networking support to meet foreign investors

Portfolio Oversight Support

Registration of company and/or joint ventures with foreign partners

Other

If other, please explain the type of support:

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EIC ACCESS+ Co-funding

Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project website.

Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.