CMG MedDev as regulatory partner for European projects

Short summary
CMG MedDev is a Spanish SME specialised in regulatory affairs and quality for health technologies. We lead regulatory work packages in Horizon Europe and Eurostars consortia. We turn research results into compliant, CE-marked and market-ready products (MDR/IVDR, SaMD, AI Act, SoHO). We offer our regulatory expertise and are looking for coordinators and partners whose projects need a regulatory and quality strategy built in from day one.

About the organisation

• Type: SME – regulatory and quality consultancy, with its own software product

• Country: Spain

• Team: senior consultants in regulatory strategy, clinical evaluation, medical device software (MDSW), and quality systems (ISO 13485, ISO 14001, ISO 45001, ISO 9001)

• Track record: leader of the regulatory work package (Health Regulatory Hub) in the HEALTHCONNECT Horizon Europe consortium of hospital TTOs; SME partner in Eurostars consortia; mentoring of selected companies in EU and FDA regulatory strategy (AstraZeneca Acción programme); member of EIT Health.

What we offer

1. Regulatory strategy “by design” for medical devices, IVDs and SaMD: intended purpose, classification, clinical evidence plan, risk management and technical documentation, aligned with TRL progression.

2. Integrated SaMD/AI compliance: MDR/IVDR + EU AI Act + EN 18286 (quality management system for AI).

3. Clinic-to-market regulatory roadmaps and regulatory screening of technologies for TTOs, hospitals and research centres.

4. Quality systems and cybersecurity/safety evidence for software-based health products.

5. Dissemination, exploitation and regulatory training (WP on impact, guidelines, toolkits and workshops).

6. Joint offer with a medical software developer (software development + regulatory/CE marking), useful for consortia that need both in one package.

What we are looking for

• Coordinators and consortia preparing 2026–2027 Cluster 1 Health proposals who need a regulatory WP leader or partner (roadmaps, regulatory strategy, clinical evidence, QMS).

• Developers of digital health, SaMD, AI-based diagnostics and medtech (SMEs, startups, spin-offs) who want to reach CE marking and market access.

• Hospitals, research centres and TTOs with technologies that need regulatory screening and a path to the clinic.

• Clinical partners and CROs for clinical investigations and post-market follow-up.

• Partners in biobanking and cell/tissue/blood (SoHO) interested in traceability and regulatory compliance.

• Notified bodies, standardisation bodies and regulatory sandboxes for exchanging expertise.

Preferred role in a consortium
WP leader or task leader for regulatory, quality and clinical evidence; also partner in exploitation, dissemination and training work packages.

Type of partner sought: Coordinator, research organisation, SME, hospital/TTO, large industry
Keywords: medical device regulation, MDR, IVDR, SaMD, AI Act, EN 18286, clinical evaluation, quality management, ISO 13485, cybersecurity, SoHO, biobanks, digital health, technology transfer, regulatory sandbox

Contact: Luis Rodriguez, luisfe.burrieza@cmgmeddev.com, www.cmgmeddev.es]