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.

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​

REGULATORY SUPPORT

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

INTERNATIONAL REGISTRATION

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

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

REGULATORY INTELLIGENCE

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

GEOGRAPHIC COVERAGE

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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,…)