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By Stage of Medical Device Development

Commercialization & Post-Market

Concept & Feasibility Analyze prototype and concept design Preclinical Development Evaluation of biocompatibility and safety. Analytical validation Clinical Development Assess safety and effectiveness, and gather data for registration and market access           Market Approval Assemble and file an application Commercialization & Post-Market Mitigate risk and remain compliant

Mitigate risk and remain compliant.

Post marketing surveillance (PMS) is organized to monitor the safety and performance of the product once used by large number of patients in the targeted population, and to ensure a sustainable risk/benefit balance.

Agreements are established with distributors in particular to define the split of regulatory responsibilities between the different stakeholders (Manufacturer/distributor). Promotional materials are developed for each market, in compliance with local regulatory requirements.

Launch, pricing, and reimbursement strategies aim to yield a favorable evidence-based assessment by national authorities, whose priorities and outcome measurement vary across markets.

The medical device’s core value dossier is adapted for local reimbursement applications.

Client Goals

Market access

Post-market surveillance to maintain compliance

Assess opportunities in new indications, product repositioning, need of additional clinical studies in new indications.

Clinical studies

Collect RW data

Manage unexpected regulatory or safety issues.

Stage of development: challenges


  • Are the post-market surveillance procedures well defined and not too burdensome? How to optimize the post-approval regulatory plan?
  • How to handle manufacturing changes/issues?
  • How to manage competitive markets?
  • How to identify additional market opportunities?
  • How to extend the indication for use?
  • Will pricing need to be re-negotiated? What will be the adequate evidence to support it?

Our Mission

Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.

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What VCLS Can Do

What VCLS Can Do - Services

VCLS Expertise