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)
MedTech Projects
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
Medical device (MDR) certification consulting
Regulatory consulting for conformity assessment, technical file preparation, gap analysis and Notified Body support for MDR compliance.
IVD (IVDR) certification consulting
Regulatory support for qualification/classification of IVDs, technical documentation, conformity assessment and IVDR compliance.
Post‑market surveillance and PMCF/PMPF services
Design and execution support for PMS systems, post‑market performance follow‑up and vigilance reporting.
QMS implementation and ISO certification support
Implementation of quality management systems aligned to ISO 13485:2016 and ISO 9001:2015 including documentation, internal audits and certification support.
UDI, device coding and database registration
Services for obtaining UDI codes, defining UDI assignment strategies, mapping to device nomenclature and registering devices in national and European databases.
PRRC (Person Responsible for Regulatory Compliance) support
Advisory and checklist services to assist companies in meeting the duties of the PRRC role under MDR/IVDR.
Medical device (MDR) certification consulting
Regulatory consulting for conformity assessment, technical file preparation, gap analysis and Notified Body support for MDR compliance.
IVD (IVDR) certification consulting
Regulatory support for qualification/classification of IVDs, technical documentation, conformity assessment and IVDR compliance.
Post‑market surveillance and PMCF/PMPF services
Design and execution support for PMS systems, post‑market performance follow‑up and vigilance reporting.
QMS implementation and ISO certification support
Implementation of quality management systems aligned to ISO 13485:2016 and ISO 9001:2015 including documentation, internal audits and certification support.
UDI, device coding and database registration
Services for obtaining UDI codes, defining UDI assignment strategies, mapping to device nomenclature and registering devices in national and European databases.
PRRC (Person Responsible for Regulatory Compliance) support
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