Consulting and Laboratory testing

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