Medical Devices

Atessia offers tailormade support on a specific project or regulatory activity affecting your medical devices (MD) and in vitro diagnostic medical devices (IVDMD)

  • Definition and classification of MD/IVDMD
  • Transition strategy to RDM
  • Responsibility of manufacturer, mandatary and distributor
  • Eudamed declaration
  • Label review
  • Drafting or updating technical files (CE marking)
  • Drafting or updating Post Market Surveillance documents
  • Assistance with responses to Notified Bodies
  • Review of design dossiers, clinical evaluation dossiers, risk management dossiers
  • Listing your essential SOPs
  • Drafting SOPs
  • Quality system maintenance
  • Regulatory review of promotional and non promotional materials
  • Submission to ANSM
  • Implementing the materiovigilance case collection system
  • Training your teams
  • Complaints management
  • Support drafting your contracts
  • Assistance on the (EU) regulation 2016/679 regarding the processing of personal data and the free circulation of such data (GDPR)
  • e-Health
  • Cybersecurity
  • Telemedicine
  • Health data hosting
  • Regulatory training
  • Declarations of transparency (transfers of value)
  • Declarations to professional bodies (anti-gift law)
  • French and European legislation
  • Atessia Intelligence Service and its formula dedicated to MD

Training

Audit

Further information

Download the document "Les dispositifs médicaux"
  • A team of experienced consultants
  • Support customed to your requirements in project mode
  • Proficiency in regulations
  • A team attuned to new technologies
  • MD subscription formula on Atessia Intelligence platform
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Explore other services of Atessia

Pharmacovigilance
Regulatory monitoring
Atessia Master Class
Research & Development Consulting
Post-MA lifecycle management