MedTech Projects
MedTech Projects specializes in innovation and safety of biomedical technologies, providing consultancy and support services for companies and public/private entities in the medical device sector, including certification, regulatory compliance, quality management systems, and training.
Industries
Nr. of Employees
small (1-50)
Products
E‑learning platform (online courses and recorded content)
Online platform hosting live webinars, recorded courses and learning materials on medical device regulation and related topics; recordings available for defined access period.
E‑learning platform (online courses and recorded content)
Online platform hosting live webinars, recorded courses and learning materials on medical device regulation and related topics; recordings available for defined access period.
Services
Regulatory consulting for conformity assessment, technical file preparation, gap analysis and Notified Body support for MDR compliance.
Regulatory support for qualification/classification of IVDs, technical documentation, conformity assessment and IVDR compliance.
Design and execution support for PMS systems, post‑market performance follow‑up and vigilance reporting.
Implementation of quality management systems aligned to ISO 13485:2016 and ISO 9001:2015 including documentation, internal audits and certification support.
Services for obtaining UDI codes, defining UDI assignment strategies, mapping to device nomenclature and registering devices in national and European databases.
Advisory and checklist services to assist companies in meeting the duties of the PRRC role under MDR/IVDR.
Regulatory consulting for conformity assessment, technical file preparation, gap analysis and Notified Body support for MDR compliance.
Regulatory support for qualification/classification of IVDs, technical documentation, conformity assessment and IVDR compliance.
Design and execution support for PMS systems, post‑market performance follow‑up and vigilance reporting.
Implementation of quality management systems aligned to ISO 13485:2016 and ISO 9001:2015 including documentation, internal audits and certification support.
Services for obtaining UDI codes, defining UDI assignment strategies, mapping to device nomenclature and registering devices in national and European databases.
Advisory and checklist services to assist companies in meeting the duties of the PRRC role under MDR/IVDR.
Expertise Areas
- Regulatory compliance for medical devices (MDR/IVDR)
- Quality management systems (ISO 13485 / ISO 9001)
- Post‑market surveillance and vigilance (PMS, PMCF/PMPF)
- UDI implementation and device nomenclature (EMDN/CND)
Key Technologies
- UDI system implementation and labeling
- European medical device nomenclature (EMDN) mapping
- Eudamed and national device database registration
- ISO 13485 / ISO 9001 QMS frameworks