CS-MD STRAT&CONSULT
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SERVICES

CS-MD STRAT&CONSULT covers the complete lifecycle of medical devices, from recommendation of the path to market, to late-stage post-marketing activities.
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CE MARK

  • Creation
  • Update / compliance with new regulation
  • Audit of existing technical documentation
  • Support for answering to questions from the Competent Authorities / Notified Body
  • Clinical Evaluation Report​
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REGULATORY SUPPORT

  • Person responsible for regulatory compliance
  • Post Market Surveillance
  • Medical Device Reporting
  • ​Promotion
  • COMEDIMS dossiers / Technical dossier for hospitals …
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INTERNATIONAL REGISTRATION

  • Recommendation of the path to market
  • Project management with local representative (compilation, review, submission of the technical documentation)



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REIMBURSEMENT

  • Availability of procedure / reimbursement code
  • Reimbursement mechanism (diagnosis-related group or fee for service)
  • Availability of add-on reimbursement
  • Availability of innovation funding
  • Reimbursement tariffs
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REGULATORY INTELLIGENCE

  • Legislation–Regulation-Standards Collection
  • Analysis of the impacts
  • Environment monitoring,  assessment and strategic application

GEOGRAPHIC COVERAGE


I have worked in international environments, and with regulatory dossiers, procedures and interactions for Europe, the U.S. (FDA) and a large number of other countries:
- Australia
- Latin America (Brazil, Mexico, Colombia, Argentina…)
- Asia (Taiwan, South Korea, Malaysia, Hong Kong, China, …)
- Middle East (Saudi Arabia, Kuwait, UAE,…)
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LINKS

Home page
About
Contact
​

CONTACT

Phone: +33 (0)760708949​
Email: caroline.soulet@gmail.com
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  • Home
  • About
  • Services
  • REGULATORY INTELLIGENCE
    • News 2020
  • Contact