We manage the interaction between companies and regulatory authorities and notified bodies so that their health products and medical devices comply with regulations.
Regulatory advice RA, ISO 9001: 2015, ISO 13485 for medical material and health products in Barcelona.
• Implementation of the new regulation MDR (EU) 2017/745.
• Implementation of new regulation IVDR (EU) 2017/746.
• Sanitary Product Classification.
• CE Marking Consultancy and Assistance
• Previous license to operate facilities.
• Advice on the preparation of technical files.
• Audits (MDSAP).
• Qualification of medical devices.
• Management of public tenders.
Technical requirements to obtain authorization to manufacture and market products with all health guarantees and in the shortest time possible.
Preparation of the technical file.
Reformatting To Ectd/Nees/Vnees.
Approval of suppliers and purchases.
Inform the regulatory authorities, sales team, product specialist and customers of the events and actions to solve them.
Manage incidents with regulatory authorities through their platforms.
Product registrations and their renewals in the regulatory authorities.
Import approval.
Review of promotional material.
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Company Details
- Founded
- -
- Address
- Barcelona, Barcelona 08002, Es
- Industry
- It Services And It Consulting
- NAICS
-
Computer Systems Design and Related ServicesOther Computer Related Services
- Website
- https://medcontrolreg.com
- Keywords
- Implementación y auditoría ISO 13485, Clasificacion producto sanitarios, Marcado CE productos sanitarios y medical devices, Licitaciones públicas de material sanitario.
- HQ
- Barcelona, Barcelona
Medical-Cr Questions
Medical-Cr's website is https://medcontrolreg.com
Medical-Cr's LinkedIn profile is https://es.linkedin.com/company/medical-cr
Medical-Cr's industry is
IT Services and IT Consulting
Medical-Cr's top competitors are
Medical Modular System S.a.,
Medical Radar,
Medical Tuset Barcelona,
Advanced Implant Alliance,
Amconsulting Medical Devices S.l.,
Maxilabor Diagnósticos,
Medsci Group,
Muon Systems,
Osteotech,
Physics Across Borders (Phyabo).
Medical-Cr's categories are IT Services and IT Consulting
Medical-Cr's founding year is 2019
