Medical Devices Scientific and Regulatory Services
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
MedTech Regulatory Roadmaps and Feasibility Assessments
MedTech EU & US Classification Strategy
MedTech EU Certification Procedure assistance: CE Marking (including selection and management of communication with Notified Bodies and Technical Documentation submission)
MedTech EU Technical Documentation preparation, compilation and maintenance (General Safety and Performance Requirements Checklist, Benefit-Risk Analysis and Risk Management activities, Clinical Evaluation Reports, Performance Evaluation Reports, Pre-Clinical Testing activities, Labelling, Post-Market Surveillance and other Technical Documentation core-parts preparation and/or evaluation)
Support for EU country-specific regulatory requirements (including assistance with local Competent Authorities communication, product registration, facilities licenses, etc.)
Support in Eudamed registration (economic operators, UDI and devices)
Assessment and training on 2017 EU Medical Device and In-Vitro
Diagnostics Regulations requirements and regulatory impact
Definition, development and implementation of Quality Management System (QMS) according to ISO 13485, US 21 CFR 820 and MDSAP
Maintenance of QMS and annual audits programme (including ISO 13485, US 21 CFR 820, UK Medical Device Regulation and MDSAP)
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