Medical Device Diagnostic
This page summarises the information available on Diagnostic Dispositif Médical. Stated purpose: helping start-ups and SMEs carry out their regulatory, quality and clinical research work. Beneficiaries listed: SMEs manufacturing a medical device (MD) or in vitro diagnostic medical device (IVD). The status, pricing and application conditions must be confirmed with the official source before any decision.
Diagnostic Dispositif Médical is listed in the Capital OS catalogue as a national scheme. Its purpose: helping start-ups and SMEs carry out their regulatory, quality and clinical research work. Before committing any spending or requesting the support, check that the scheme is available, the eligibility criteria and the version of the rules that applies to your situation.
Funded by Bpifrance
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Who can apply
Beneficiaries listed in the catalogue: SMEs manufacturing a medical device (MD) or in vitro diagnostic medical device (IVD).
Eligibility conditions
Detailed conditions are not provided in the catalogue. Ask the managing body for the current rules or specifications.
What the scheme covers
Purpose and services listed: an 18-month service by a consultant listed by Bpifrance. Part 1: setting up a quality management system meeting the harmonised European standard ISO 13485. Part 2: creating or updating the technical documentation for CE marking of class IIa, IIb or III medical devices, or class B, C or D IVD devices. Part 3: designing and writing a clinical investigation protocol to demonstrate the clinical and/or health-economic benefit of a device already CE-marked or about to be, compared with the reference treatment strategy, to support the business model and provide evidence for the product's value.
Amount and funding terms
Catalogue indication, to be confirmed: an assessment costing €15,000 to €110,000 excluding VAT, 50% covered.
How to apply
1. Check that the scheme is still available on the date of your request. 2. Confirm the eligibility of the company and the eligible costs or services. 3. Obtain the up-to-date rules or specifications. 4. Check whether the application must be made before signing a quote, starting the work or making the purchase. 5. Keep quotes, receipts and proof of completion. The exact application procedure for this scheme remains to be confirmed.
Timeline
No end date is given in the source catalogue. Check the current official timetable.
Key facts
- Funder
- Bpifrance
- Type of funding
- Grant
- Status
- Ongoing
- Maximum amount
- €110,000
- Automatically extracted — check the official source
- Minimum amount
- €15,000
- Automatically extracted — check the official source
- Funding rate
- 50%
- Automatically extracted — check the official source
- Geographic scope
- All of France
Frequently asked questions
What is Diagnostic Dispositif Médical for?
The catalogue describes it as follows: helping start-ups and SMEs carry out their regulatory, quality and clinical research work. The current scope of the scheme remains to be confirmed in the official source.
Who can apply for Diagnostic Dispositif Médical?
The catalogue states: SMEs manufacturing a medical device (MD) or in vitro diagnostic medical device (IVD). This does not replace checking the criteria and exclusions of the applicable rules.
What funding or coverage is provided?
an assessment costing €15,000 to €110,000 excluding VAT, 50% covered. This amount comes from the catalogue page and should be checked against the current official conditions before being used as an estimate.
What steps and precautions should I plan for Diagnostic Dispositif Médical?
Services described: an 18-month service by a consultant listed by Bpifrance. Part 1: setting up a quality management system meeting the harmonised European standard ISO 13485. Part 2: creating or updating the technical documentation for CE marking of class IIa, IIb or III medical devices, or class B, C or D IVD devices. Part 3: designing and writing a clinical investigation protocol to demonstrate the clinical and/or health-economic benefit of a device already CE-marked or about to be, compared with the reference treatment strategy, to support the business model and provide evidence for the product's value. Detailed conditions are not sufficiently documented in the catalogue. Check that the scheme is open, whether you must apply before committing costs, and the documents required before any decision.
Official source
No official URL is available in our data for this grant.
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