SAFE-N-MEDTECH · Project

One-Stop Safety Testing Platform for Nano-Enabled Medical Devices

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Imagine you invented a tiny medical implant using nanotechnology — maybe a better dental filling or a smarter cancer diagnostic chip. Before you can sell it, you need to prove it's safe. But the testing rules for nano-sized materials in medical devices are still catching up, and no single lab can do all the tests you need. SAFE-N-MEDTECH built a shared testing platform across 16 countries where companies can get their nano-enabled medical products tested, assessed, and validated — from early development all the way to market entry.

By the numbers

partner organizations in the consortium

countries represented in the testing network

industry partners providing commercial testing infrastructure

SMEs in the consortium

total deliverables produced

The business problem

What needed solving

Companies developing medical devices with nanotechnology face a fragmented and unclear safety testing landscape. No single lab can perform all required assessments — biocompatibility, electromagnetic compatibility, nano-specific toxicology — and the regulatory requirements for nano-enabled products are still evolving. This delays time-to-market and increases costs, especially for SMEs that lack in-house testing infrastructure.

The solution

What was built

An Open Innovation Test Bed (OITB) — a coordinated platform offering safety testing services across the full medical device lifecycle. Concrete deliverables include training modules for researchers and company staff on nano-enabled medical technology development, a database of technology choices and comparators for individual nano-enabled medical technologies, and a public website for accessing the platform's services.

Audience

Who needs this

Medical device SMEs adding nanomaterials to implants or prostheticsIn vitro diagnostics companies developing nano-based biosensorsDental materials manufacturers using nano-compositesOrthopaedic device companies with nano-coated implantsContract testing laboratories seeking standardized nano-safety protocols

Business applications

Who can put this to work

Medical device manufacturing

SME

Target: SMEs and mid-size companies developing implants, prosthetics, or diagnostic devices with nanomaterials

If you are a medical device manufacturer struggling to get your nano-enabled implant through regulatory safety testing — this project built an open-access testing platform across 37 partner organizations in 16 countries that covers biocompatibility, electromagnetic properties, and lifecycle assessment. Instead of hunting for the right lab yourself, you access a coordinated network with standardized protocols.

In vitro diagnostics

any

Target: Companies developing nanotechnology-based diagnostic tests and biosensors

If you are a diagnostics company developing nano-based biosensors or rapid tests and need safety validation before market launch — this project created a database of technology choices and comparators for individual nano-enabled medical technologies. The platform offers testing services that cover the full product lifecycle from development through upscaling.

Dental and orthopaedic materials

mid-size

Target: Companies producing dental implants, bone cements, or orthopaedic devices with nano-coatings

If you are a dental or orthopaedic materials company adding nano-coatings or nano-composites to your products and facing complex safety qualification — this project specifically addressed dentistry and orthopaedics applications. Their training modules prepare your R&D workforce for the critical steps in nano-enabled medical technology development.

Frequently asked

Quick answers

How much does it cost to use this testing platform?

The project built an Open Innovation Test Bed designed as an open-access platform for companies. Specific pricing for testing services is not published in the available project data. Contact the coordinator to discuss service fees and access terms.

Can this platform handle industrial-scale testing or just lab samples?

The platform was designed to support testing, assessment, upscaling, and market exploitation across the whole product lifecycle. With 37 partners including 10 industry organizations, the infrastructure spans from material characterization to production-scale validation. Based on available project data, the OITB covers development through market entry.

What about intellectual property — who owns the test results?

As an Open Innovation Test Bed, the platform is designed for open access to companies and reference laboratories. Based on available project data, IP arrangements for specific testing engagements would need to be discussed directly with the consortium. The platform model suggests results belong to the client company.

Does this help with EU MDR regulatory compliance?

The project directly addresses risk/benefit assessment for nano-enabled medical technologies, which is a core requirement under medical device regulations. The platform covers biocompatibility, electric compatibility, and electromagnetic properties testing — all critical for regulatory submissions. Training modules also cover regulatory-relevant development steps.

How long does a typical safety assessment take?

Based on available project data, the platform covers the full lifecycle from development through market exploitation. Specific timelines for individual assessments are not published in the project documentation. The coordinated multi-partner approach is designed to reduce the time companies typically spend finding and sequencing the right tests.

What medical areas does the testing platform cover?

The project explicitly covers cancer diagnostics, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry applications. The platform handles nanomaterials characterization, biocompatibility, electromagnetic properties, and electric compatibility testing across these medical areas.

Is the platform still operational after the project ended?

The project closed in September 2023. Based on available project data, the OITB was designed for long-term market operation beyond the project period. The project website at safenmt.eu should indicate current availability of testing services.

Consortium

Who built it

With 37 partners across 16 countries, this is a large and geographically diverse consortium — one of the bigger Open Innovation Test Beds in the medical technology space. The mix includes 14 research organizations, 10 industry players, 6 universities, and 7 other entities. The 27% industry ratio and 5 SMEs suggest a balance between scientific depth and market orientation. The consortium spans the EU with partners in Spain, Germany, France, Italy, the Netherlands, and the Nordics, plus non-EU participants from China, Colombia, and the UK. Coordination sits with a Spanish health innovation foundation (BIOEF). For a company seeking safety testing services, this breadth means access to diverse regulatory expertise and testing capabilities across multiple European markets.

BIOKERALTY RESEARCH INSTITUTE AIEparticipant · ES
VLAAMSE INSTELLING VOOR TECHNOLOGISCH ONDERZOEK N.V.participant · BE
EUROSCAN INTERNATIONAL NETWORK EVparticipant · DE
STRYKER TRAUMA GMBHparticipant · DE
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD, OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLINparticipant · IE
TECNALIA SERBIA DOO BEOGRADthirdparty · RS
FUNDACION TECNALIA RESEARCH & INNOVATIONparticipant · ES
NATIONAL CENTER FOR NANOSCIENCE AND TECHNOLOGYparticipant · CN
TECNOLOGIA NAVARRA DE NANOPRODUCTOS SLparticipant · ES
COUNCIL OF EUROPEAN BIOREGIONSparticipant · BE
FUNDACAO GIMM - GULBENKIAN INSTITUTE FOR MOLECULAR MEDICINEparticipant · PT
SINTEF ASparticipant · NO
HELIA BIOMONITORING BVparticipant · NL
UNIVERSITA DEGLI STUDI DI PAVIAparticipant · IT
INSTITUTUL DE CHIMIE FIZICA - ILIE MURGULESCUparticipant · RO
GREENDECISION SRLparticipant · IT
THE UNIVERSITY OF LIVERPOOLparticipant · UK
FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIASthirdparty · ES
BIOCAT LA FUNDACIO BIOREGIO DE CATALUNYAthirdparty · ES
UNIVERSITE D'AIX MARSEILLEthirdparty · FR
DEPARTAMENTO DE SALUD GOBIERNO VASCOparticipant · ES
TECHNISCHE UNIVERSITEIT EINDHOVENparticipant · NL
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRSparticipant · FR
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCAparticipant · ES
RESONANT CIRCUITS LIMITEDparticipant · UK
INTERNATIONAL IBERIAN NANOTECHNOLOGY LABORATORYparticipant · PT
BUSINESS TURKU OY ABthirdparty · FI
CONSORCIO CENTRO DE INVESTIGACION BIOMEDICA EN RED M.P.participant · ES
STATENS ARBEIDSMILJOINSTITUTTparticipant · NO

How to reach the team

Coordinator is FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS (Spain) — a Basque health innovation foundation. Search for SAFE-N-MEDTECH project coordinator contact or check the project website.

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Next steps

Talk to the team behind this work.

Want to access nano-medical device safety testing services from this 37-partner European network? SciTransfer can connect you with the right testing partners for your specific product.

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