Skip to main content

Consulting and Laboratory testing

We support medical device manufacturers from development to certification in Europe and worldwide.

Committed to your project’s success

In a complex and ever-changing environment, every stage of your medical device development is crucial to ensuring its safety, efficacy, and compliance. Our dedicated teams assist you in addressing these challenges and in accelerating your product’s time-to-market.

Your project, our expertise: Tailored support for you

Whether you are an innovative startup or an international company, we support you at every stage of your medical device’s lifecycle, from development to certification. With a tailored approach based on your needs, we offer turnkey or customized support.

Backed by 15 years of expertise, strengthened by our own innovations in packaging and manufacturing processes, our experts offer both technical and regulatory assistance to develop the most suitable market entry and development strategies for your device.

From development to certification of your medical device

R&D

Innovation is at the core of our DNA, and our R&D team brings your concepts to life, based on the needs and requirements of the products, processes, and methods you wish to develop.

  • Design of medical devices.
  • Packaging design.
  • Design of medical devices accessories.
  • Development of specialized processes.
  • Feasibility study of the initial specifications and technical advisory within the area of expertise for its finalization.

Verification & Validation

Our experts assist in developing validation strategies and providing the necessary deliverables.
Through our proprietary validation ressources, we enable significant costs savings and faster market access.

  • Development of validation strategies and creation of validation files for critical processes with drafting of protocols and reports (final cleaning, single or double-barrier packaging, and sterilization). 
  • Equipment and production tool qualification (sealing, assembly, injection molding, etc.) following Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) principles.
  • Process validation according to Operational and Performance Qualification principles. 
  • Updating customer validation files.
  • Cleanroom qualification support, implementation of monitoring plans, and risk management.
  • Final sterile product validation according to QPP principles.

Industrialization

To overcome obstacles and guide you toward the most optimal solutions, our industrialization specialists support and advise you on the technical feasibility of your project, ensuring its successful transition to production.

  • Technical support: assembly, cleaning, packaging, surface treatment, sterilization methods, optimization of plastic injection-molded components.
  • Creation of manufacturing flow and process planning specific to your medical devices.
  • Development of custom components and production tools.
  • Packaging definition: visual design of products and labeling in compliance with customer requirements and regulations.
  • Project planning and tracking in coordination with customer qualification/validation services.

Regulatory and compliance support

We provide personalized support for the development of your technical file, with a consulting approach tailored to your device, in compliance with specific regulatory requirements.

  • Audit of the Quality Management System (QMS) and/or manufacturing processes. Development of action plans and support.   
  • Implementation or compliance update of the Quality Management System.
  • Establishment of control methods.
  • Drafting or updating of the technical file for CE marking or 510K submission.
  • Assistance with certification audits/inspections and responses to non-compliance (NCs).  
  • Drafting of regulatory analysis for medical devices and its impact on existing products/processes.
  • Support in change management.

Laboratory testing phase

We conduct a wide range of in-house tests in our laboratories and prepare the associated protocols while collaborating with certified partners to expand our testing capabilities.

Mechanical testing laboratory & sterile barrier system characterization

  • Tensile/compression testing
  • Seal strength testing ASTM F88/F88M and ISO 868-5
  • Dye penetration testing ASTM F1929 and ASTM F3039
  • Visual inspection ASTM F1886
  • Bubble leak test ASTM F2096
  • Transportation simulation ASTM D4169
  • Aging tests in controlled environments ASTM F1980


Dimensional measurement & surface analysis laboratory

  • Wettability testing NF EN ISO 19403-2, – NF EN ISO 19403-3, – NF EN 828
  • SEM/EDS : Scanning Electron Microscopy (SEM) with Energy Dispersive X-ray Spectroscopy (EDX)
  • 3D Coordinate Measuring Machine (CMM)
  • Surface tensiometer: for surface tension (surface energy) measurement
  • Roughometer for roughness measurement


Microbiological analysis & surface residue testing laboratory

  • Bioburden testing NF EN ISO 11737-1
  • Endotoxin testing NF EN ISO 11737-3 – EU 2.6.14  – USP <85>
  • Biocompatibility testing ISO 10993 series
  • THC testing NF EN 1484 et ASTM F2459-18 et ASTM G 136
  • TOC testing NF EN ISO 9377-2 et ASTM F2459-18 et ASTM G 136
  • Inorganic residue testing NF EN ISO 10304-1 et ASTM F2459-18 et ASTM G 136
  • Particulate residue testing USP <788>
  • Sterility testing NF EN ISO 11737-2
  • Dose audit NF EN ISO 11137-1 et NF EN ISO 11137-2

Our expert teams’ thorough understanding of regulatory authority requirements allows them to guarantee the quality and compliance of your solutions.

Discover our innovations

Our expertise in consulting and laboratory
testing serving diverse markets

dentaire

Dental

orthopedie

Orthopedics

tissous-mous

Soft Tissues

diagnostic

Diagnostics

robotique

Robotics

Discover our expertise

Complete expertise for your project.

Let’s get started!

Share your challenges with us, we are ready to support you.