Summary
- Profile Type
- Business Offer
- POD Reference
- BOES20250206017
- Term of Validity
- 7 February 2025 - 7 February 2026
- Company's Country
- Spain
- Type of partnership
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- As a young Spanish women lead company, founded by experienced senior professionals with health regulations and manufacturing expertise, their agile and personalized service delivery helps medtech, biomedical and medical devices companies, reach markets (EU/USA/LATAM) ensuring regulatory requirements for CE marking and FDA approval. Following their growth strategy, the company seeks for new partners to expand their market reach. Collaboration is offered under commercial agreements.
- Full Description
-
Founded in 2022, the Spanish company has grown from 2 to 10 employees while gaining a solid track record of more than 250 projects. Company CEO is a thirty years experience woman, with a very strong background in medical devices, IVD and medical SW companies. Team members hold pharmacy, biology and related lifesciences degrees, helping to create strong client relationships. Working under lean and agile premises, the company has been able to serve more than 250 clients/projects and has built a solid partners and value network within the different Spanish health innovation regional ecosystems.
Their service portfolio categories comprise: regulatory, quality, medical writing, clinical services, approval and registrations, CE mark submissions, FDA pre-submissions & submissions, Eudamed registration, Notified Body and NCA response resolution and trainings MDR/IVDR, ISO13485, 15189/ 14971 /14155 / 20916, cybersecurity and usability assessment.
Their relations with associations, clusters, universities, and innovation hubs with access to valuable specialized experts and companies has been determinant in setting their growth goals under a twofold national/international pathway.
Business collaboration is sought at first with European and Non-European companies and/or service providers that help similar client companies to develop in the European market. Their second focus is on bringing the European and Non-European companies that want to enter and develop the USA / FDA market. - Advantages and Innovations
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Company advantages come from their team experience, lean structure, agile processes and their service portfolio selection. Born within the digital transition, the company acts as a one stop shop aiming to provide a unique client journey experience, combining in depth knowledge with a personalized treatment and fast and reliable results.
Their actual services portfolio comprises:
*Services for medical devices, in vitro diagnostic, medical SW and AI.
Supporting the development and registration of medical devices. Such as class I to class III devices, including software, in vitro diagnostic and drug-device combination products worldwide. Popular services are quality management system implementation, clinical evaluation and product qualification. This diverse field encompasses everything from simple devices like needles to complex technologies such as MRI scanners.
*Regulatory operation services
Making sure that an application conforms with all other requirements beside the scientific requirements, the company service has being built to support regulatory operations and provide publishing services. Popular services are pre-submission and submission preparation support, electronic submission support, document management system (DMS) support and regulatory information management (RIM).
Regulatory Operations services are essential in Regulatory Affairs, streamlining submissions and ensuring seamless compliance for biotech products and medical devices. - Technical Specification or Expertise Sought
- Company looks for life science, biomedical or medtech service provision individual or company experts with experience or knowledge regarding e-health/digital health/medtech/medical devices, operations, manufacturing or regulatory processes. Expertise regarding AI tools, digital doc processing, and special software regarding regulatory operations and registration of medical devices is welcome.
- Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- Goal 9: Industry, Innovation and Infrastructure
Partner Sought
- Expected Role of a Partner
-
Type of partner:
Company or service provider active in the healthcare market.
Role of the partner:
A company or service provider that supports a European or Non-European company to enter the European, LATAM or USA market. - Type and Size of Partner
- Big company
- SME 50 - 249
- SME 11-49
- R&D Institution
- SME <=10
- University
- Type of partnership
- Commercial agreement
Dissemination
- Technology keywords
- 06002007 - In vitro Testing, Trials
- 01004001 - Applications for Health
- 06001013 - Medical Technology / Biomedical Engineering
- 06001002 - Clinical Research, Trials
- 01003003 - Artificial Intelligence (AI)
- Market keywords
- 02007012 - Medical/health software
- 04009 - In vitro Testing, Trials
- 05001002 - In-vitro diagnostics
- 02007016 - Artificial intelligence related software
- Sector Groups Involved
- Digital
- Health
- Targeted countries
- All countries
Files
Service Portfolio