RegNav

Service description

The future of medical device compliance: intelligent, automated, reliable. RegNav combines expert insights with AI, giving you a complete picture of your safety and performance requirements. Save time, reduce stress, and focus on bringing your innovation to market. Developing a medical device is thrilling, but navigating regulations can be daunting. RegNav bridges that gap. Our AI and expert guidance tool creates a product-specific roadmap for you, streamlining the journey through clearance or approval. For 20 years, Element has ensured the safety and integrity of countless critical products. Leveraging Element’s global expertise and trusted reputation, RegNav guides you seamlessly through compliance, accelerating your path to market. Don't just trust technology, trust the integrity, care, and progress that defines Element. RegNav offers:

RegNav Premium - A full compliance plan, product classification, and timeline:

• Who it is for: Companies with devices pre- or post-design freeze that want to get ahead of regulation and ensure they are well-prepared for a smooth submission.

• What you get: You will receive a full outline of your pathway, product code, regulations, and requirements for your submission.

Expert validation of an existing compliance plan:

• Who it’s for: Companies that have an existing compliance plan and want to be confident that they have a comprehensive plan for submission.

• What you get: A double-checked and expert-backed review of your standards, identifying any gaps ahead of submission.

Sector

Health and medical care

Technology Readiness Level

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

RegNav Premium - A full compliance plan, product classification, and timeline: €10,000.

Expert validation of an existing compliance plan: Free assessment + €2,500 to unlock new standards (if a discrepancy to your existing compliance plan is identified).

Disclaimer related to service

This compliance plan is issued in accordance with the Element Materials Technology Limited Terms and Conditions for use of RegNav, and is for the exclusive use of the persons to whom it is addressed and their advisers and must not be copied, reproduced or distributed (in whole or in part) or disclosed by recipients to any other person. By accepting this compliance plan, the recipient agrees to be bound by the Element Materials Technology Limited Terms and Conditions for use of RegNav, which can be found here: https://www.regnav.com/terms-and-conditions.

Applicants should carefully read the “Terms of Engagement for EIC beneficiaries” before submitting this application form.

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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.

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

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

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At which Technology Readiness Level is your innovation or solution?

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

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Type of support

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

Type of partners (type of organisations)

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Purpose for the partnership

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Type of support (Business modelling)

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Why do you need this service?

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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)

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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

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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:

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What type of due diligence service are you looking for?

Investment readiness

Legal

Environmental

Technological

I need technical support for product or service valuation

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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

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Why do you need this Prototyping & PoC service?

I need technical support for prototyping of product or service development

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I need access to expert guidance for prototyping

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Support for validation of the prototype or PoC with end users

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What type of service are you looking for?

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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

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Element Materials Technology

Service ID:

Intellectual Property & Legal

Applicants should carefully read the “Terms of Engagement for EIC beneficiaries” before submitting this application form.

1. Background information about the EIC beneficiary

2. Information related to the service provision

Connect with innovators across Europe