Submed

Company Overview

SUBMED is a medical device and medical consumables manufacturer with strong expertise in the development, validation and industrialisation of patient-centred health technologies.

The company operates under ISO 13485 Quality Management System and has extensive experience in biocompatibility assessment, sterilisation validation, antimicrobial efficacy testing and regulatory-compliant product development. SUBMED bridges applied R&D and market-ready solutions, supporting the translation of innovative technologies into safe and compliant medical products.

Core Expertise & Capabilities

• Medical device development and validation (single-use medical products, wound care and procedure-related solutions)

• ISO 10993 biocompatibility testing strategies and preclinical safety assessment

• Antimicrobial efficacy and performance validation

• Sterilisation processes and validation (industrial and regulatory perspective)

• ISO 13485 quality management, risk management and regulatory compliance

• Experience with alternative in vitro testing approaches and industrial validation workflows

• Strong capability to provide real-world industrial case studies for research projects

Relevance to Horizon Europe – Health Cluster

SUBMED is particularly well aligned with Horizon Europe calls related to:

• New Approach Methodologies (NAMs) and animal-free testing

• Regulatory science supporting translational development

• Validation and standardisation of innovative health technologies

• Industry uptake of research outcomes and pilot implementations

Expected Role in Projects

SUBMED typically contributes as an industrial end-user, pilot partner or validation lead, providing:

• Validation of novel methods and technologies on real medical device prototypes

• Translation of academic research outputs into industry-ready and regulatorily acceptable solutions

• Input on manufacturability, quality assurance, regulatory pathways and patient safety

• Pilot demonstrations supporting standardisation, scalability and market adoption

Value Proposition for Consortia

• Ensures industrial relevance and regulatory credibility of project outcomes

• Reduces the gap between research innovation and real-world implementation

• Provides practical insight into regulatory expectations and quality requirements

• Strengthens exploitation potential and impact pathways

Targeted Horizon Europe Topics

• HORIZON-HLTH-2026-01-TOOL-03 – Integrating New Approach Methodologies (NAMs)

• HORIZON-HLTH-2026-01-IND-03 – Regulatory science for patient-centred health technologies

• HORIZON-HLTH-2026-01-TOOL-06 – Accelerating NAMs for medicinal products and medical devices

Contact

SUBMED is open to joining EU-funded collaborative research projects as an industrial partner, validation lead or pilot end-user, particularly in projects aiming to translate research into safe, compliant and impactful healthcare solutions.