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Voisin Consulting Life Sciences
France
Medical Device Validation: V&V services for ISO 13485 compliance
Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Regulatory Affairs: Documentation and filing for global market access

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Voisin Consulting Life Sciences (VCLS) is a global product development and regulatory consulting firm headquartered in Boulogne-Billancourt, France. With an international workforce of more than 250 life sciences specialists across Europe, the US, and Asia, VCLS guides pharmaceutical, biotechnology, and medical device developers from bench research through to commercialization.

For MedTech, digital health, and combo product developers, VCLS provides strategic guidance aligning European CE marking and US FDA pathways. The firm specializes in early design-level compliance, verification planning, clinical evidence determination, and agency interaction to streamline approval timelines on both sides of the Atlantic.

Offer

Voisin Consulting Life Sciences offers comprehensive regulatory, clinical, and compliance development programs for health technologies:

  • Transatlantic Regulatory Strategy (CE vs. FDA): Dual-pathway planning harmonizing European MDR 2017/745 / IVDR 2017/746 requirements with US FDA 510(k), De Novo, and PMA submission requirements.
  • Design-Level Prep & Clinical Risk Management: Establishing early design control architectures, clinical risk management plans, and risk-benefit determinations aligned with ISO 14971 and ISO 13485.
  • Technical Documentation & Dossier Compilation: Drafting, structuring, and defending Technical Documentation and Design Dossiers for EU Notified Bodies and FDA reviewers.
  • Software & Digital Health Compliance: Regulatory roadmaps, verification protocols, and clinical evaluation strategies for Software as a Medical Device (SaMD) and AI-driven diagnostics.
  • Interaction with Competent Authorities: Coordination and representation during FDA Pre-Submission meetings (Q-Subs) and formal consultations with European National Competent Authorities and Notified Bodies.

Tags

ce marking
iso 13485
fda submissions
regulatory consulting
medtech
clinical evaluation
digital health
Industrial Specializations: Medical Device Validation: V&V services for ISO 13485 compliance, Regulatory Affairs: Documentation and filing for global market access, and Regulatory & Compliance Consulting: Design-level prep for CE/FDA/UL standards
Headquarter/main address: 64 avenue Pierre Grenier
Boulogne-Billancourt
ÃŽle-de-France 92100
France
Get Directions
https://voisinconsulting.com
Business Type: Service Provider
Ownership: Private
Employees: 250 - 499
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