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By Stage of Medical Device Development

Market Approval

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

In Europe, CE marking procedures assess both the medical device technical file and the manufacturer’s Quality Management System (QMS) to ensure compliance with applicable regulations; the same applies to the UKCA marking process in the UK. The situation is different in the US, where Pre-Market Notification (510(k)), De Novo Classification Request or Pre-Market Approval (PMA) is required to enter the US market, with varying QMS inspection timelines (pre or post market approval) depending on the submission type.

Technical dossiers provide comprehensive information about the product and quality assurance, enabling regulatory bodies to assess quality, safety and efficacy/performance in light of bench tests, preclinical and clinical data comparatively with the state-of-the-art as well as vigilance and post-marketing surveillance systems in place. The aim of the assessment is device certification or market authorization, which is when the company is allowed to lawfully market their products into applicable regions.

Commercial launch is prepared in parallel to registration. Based on registration labels and claims, the product’s value proposition is finalized, and the launch strategy is refined.

Client Goals

Regulatory strategy and submission

Compile, submit and manage device registrations

Finalize regulatory certification dossiers.

Detail roadmaps for submitting applications internationally.

Risk management

Set up Risk Management Plan (RMP)

Finalize post-market surveillance and transition to post-marketing requirements.

Set up post-marketing surveillance plan if applicable.

Stage of development: challenges


  • What are the applicable procedures & requirements for registration in targeted markets?
  • How to adapt registration applications to multiple international markets?
  • How the vigilance system can meet all applicable international requirements?
  • What are the key regulatory provisions in distributors’ agreements?
  • Which market to focus on first?
  • How to approach payers and purchasers?
  • Are promotional materials regulatory-compliant?
  • How to consolidate the product value dossier and prepare it for adaptation to local markets?
  • How to prepare for negotiations with payers?

Our mission

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

Advance with us

What VCLS Can Do

What VCLS Can Do - Services
  • Streamline the entire submission process from preparing the technical file to submission.
  • Flexible vigilance needs to ensure device quality and regulatory compliance
  • Auditable Quality Management System (QMS) by regulatory agencies as well as tailored to the organization’s needs

VCLS Expertise