Medagent, Inc.
Consultancy and service provider for medical device and in‑vitro diagnostic (IVD) regulatory compliance and market entry with ~25 years' activity. Services include international regulatory submissions and liaison, local market representation (EU/UK/US/Brazil/Australia), outsourced regulatory roles (PRRC) and data-protection officer services, QMS implementation and audit support (ISO 13485, MDSAP), validation and testing coordination, clinical-evidence support, and digital solutions for technical documentation, regulatory change monitoring, validation lifecycle management and e-learning. Offers specialized support for IVDR compliance, performance evaluations, and EUDAMED/UDI registration.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Modular digital regulatory compliance platform
Cloud-capable platform and managed service for automated technical documentation, continuous regulatory change monitoring, validation lifecycle surveillance and e-learning for regulatory and quality topics. Includes templates and workflows to support IVD-specific documentation and performance-evaluation tracking.
Modular digital regulatory compliance platform
Cloud-capable platform and managed service for automated technical documentation, continuous regulatory change monitoring, validation lifecycle surveillance and e-learning for regulatory and quality topics. Includes templates and workflows to support IVD-specific documentation and performance-evaluation tracking.
Services
End-to-end support for regulatory strategy, dossier preparation and submission across jurisdictions with coordination of notified bodies and competent authorities.
Provision of local legal/regulatory representation and liaison services including EU Authorized Representative, UK Responsible Person, U.S. Agent, Brazilian Registration Holder and TGA sponsor representation.
Provision of an outsourced PRRC to meet EU MDR/IVDR responsibilities including oversight of compliance, reporting and documentation maintenance.
Design and implementation of QMS per ISO 13485, internal and external audit preparation, MDSAP alignment and support for certification processes.
Validation planning and execution for manufacturing processes, software systems and analytical methods (DQ/IQ/OQ/PQ) and accelerated validation options for time-critical projects.
Support for PMS planning, vigilance reporting, safety updates and ongoing compliance monitoring for market authorization holders.
End-to-end support for regulatory strategy, dossier preparation and submission across jurisdictions with coordination of notified bodies and competent authorities.
Provision of local legal/regulatory representation and liaison services including EU Authorized Representative, UK Responsible Person, U.S. Agent, Brazilian Registration Holder and TGA sponsor representation.
Provision of an outsourced PRRC to meet EU MDR/IVDR responsibilities including oversight of compliance, reporting and documentation maintenance.
Design and implementation of QMS per ISO 13485, internal and external audit preparation, MDSAP alignment and support for certification processes.
Validation planning and execution for manufacturing processes, software systems and analytical methods (DQ/IQ/OQ/PQ) and accelerated validation options for time-critical projects.
Support for PMS planning, vigilance reporting, safety updates and ongoing compliance monitoring for market authorization holders.
Expertise Areas
- Regulatory submissions and international market access (EU, US, UK, Brazil, Australia)
- IVDR compliance, classification and transition planning for in‑vitro diagnostics
- Local representation and authorized representative services (EU AR, UK RP, U.S. Agent, Brazilian Registration Holder, TGA sponsor)
- Quality management systems (ISO 13485) implementation and audit readiness
Key Technologies
- Cloud-based technical documentation management
- Automated dossier assembly and version/change tracking
- Regulatory change monitoring systems
- Validation lifecycle monitoring tools
News & Updates
Compact online format providing updates on current regulatory developments in medical technology.
Overview of FDA classification, submission routes (510(k), PMA, De Novo), U.S. Agent requirement and timelines.
Overview of Spain-specific registration obligations, AEMPS registration process, local language and reimbursement requirements.
Summary of the change from FDA QSR to QMSR, alignment with ISO 13485 and recommended preparatory actions for manufacturers.
Analysis of recent US tariff developments, impacts on supply chains and recommendations for manufacturers to adapt market and regulatory strategies.
Discussion of the interplay between MDR/IVDR, the EU AI Act and GDPR, and recommended actions to harmonize quality management, AI governance and data protection.
Compact online format providing updates on current regulatory developments in medical technology.
Overview of FDA classification, submission routes (510(k), PMA, De Novo), U.S. Agent requirement and timelines.
Overview of Spain-specific registration obligations, AEMPS registration process, local language and reimbursement requirements.
Summary of the change from FDA QSR to QMSR, alignment with ISO 13485 and recommended preparatory actions for manufacturers.
Analysis of recent US tariff developments, impacts on supply chains and recommendations for manufacturers to adapt market and regulatory strategies.
Discussion of the interplay between MDR/IVDR, the EU AI Act and GDPR, and recommended actions to harmonize quality management, AI governance and data protection.