Asphalion provides comprehensive regulatory support during development, validation, certification and maintenance of Medical Devices (MD).
Gap analysis of available technical documentation and quality management system to align with MDR requirements
According to the recent change in the Medical Devices Regulation, Asphalion experts are offering a series of key solutions to support you over the whole life-cycle of your medical device.
Writing and reviewing support to implement any necessary changes in technical documentation or QMS procedures
Support in clinical evaluation plans and reports, post-market clinical follow-up plans and reports
Support in post-market surveillance plans and reports
Strategic support to define a compliance action plan to meet deadlines and grace periods
Adaptation of your quality management system
Support in EUDAMED registration
Support in compliance activities and maintenance of CE certifications
Our team of experts supports you over the whole life-cycle of your medical device, from its initial conception to CE marking and beyond post-commercialisation.
Regulatory strategy, feasibility assessment, classification analysis.
Design & development
Risk management, Testing and verification study plans, Pre-clinical and Clinical, Development plans.
CE marking & placing on the market
TD acc MDR, Management with NBs, non-conformities, UDI, EUDAMED.
PMS Reports, Incident Management, PMCF reports.
Risk management update, QMS audits, Technical vigilance, Trainings.
Asphalion is a team of senior experts with 20+ years of experience in Medical Device Regulations.
Including development, CE marking and maintenance.
Thanks to our expertise, our team is able to manage tight timelines and critical submissions.
"Comply with the new Medical Device Regulation with our advice. Contact us now and an expert will get back to you."
Regulatory Affairs Director Medical Devices
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With the recent update of the article 117, we have recently seen the regulations for Medical Devices evolve.
New classification rules
New conditions that will need to be addressed for most legacy devices
Enlarged list of General Safety and Performance Requirements (GSPRs)
Emphasis on transparency (EUDAMED) and traceability (Unique Device Identification or (UDI)
Specific classification rules and GSPRs for particular products and technologies (SaMD, nanotechnologies, substance-based devices, etc.)
Proactive Post-Market Surveillance and Vigilance processes to be defined and implemented
New mandatory roles (Person Responsible for Regulatory Compliance or PRRC)
Enhanced emphasis on risk management and clinical evidence. Update of clinical data, technical documentation and labelling
Substance-based ADME/Tox report and Biocompatibility according to ISO 10993:2018
Common specifications for particular products and technologies
Software (SaMD) Software validation, clinical evaluation plan and report
New players (expert panels) and increased scrutiny in conformity assessment procedures for high-risk devices
Specific requirements for integral drug device combinations (Article 117)