LEAMAN'ING

Tailored medical devices consulting

Thanks to a multidisciplinary and pragmatic approach, Leaman’Ing supports your company with:

OUR SERVICES

Our team gathers relevant know-how to adress challenges : discover our expertise below.

Design transfer | Equipment qualifications | Process validation | Technical transfer | Process scale-up
Quality Management Systems | Product quality | Certification bodies management  | Internal & external audit
Certification path | Technical documentation  | Market registration | Submission and answers | Regulatory watch | Post-Market Surveillance
Solution crafting & Innovation | CAD | Numerical modelling & simulation | Prototyping  | Experimentation | Data Analysis | Design History Files
Ressources planning  | Purchasing | Procurement | Manufacturing  | Warehousing

KEY BENEFITS

Quick access to Medtech competencies

No HR commitment

Low impact on Burning rate

Customized support

MAIN ACHIEVEMENTS

From idea to market, and with a particular track record on Medical Devices :

  • Proof of Concept as an outcome of research in medical technology
  • ISO13485:2016 QMS & successful certifications and renewals
  • Design History Files compliant with ISO 13485 and US Design Control Guidance
  • MDR (up to Class III) Technical Files creation & submission
  • Manufacturing sites design and implementation for Medical Devices
  • Supply Chain tools, processes and optimization for efficiency and productivity level up
  • Tuning quality and regulatory activities to reach business goals.

Contact us