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

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.

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).

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?

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

I need to get technical support for product or service development

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Why do you need this IP & Legal service?

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

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

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What type of due diligence service are you looking for?

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Legal

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I need technical support for product or service valuation

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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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Expansion and investment readiness assessment

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Element Materials Technology

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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