CONTRACT DEVELOPMENT ORGANIZATION – CDO

ORIOS LifeSciences is a Contract Development Organization supporting medical device companies in the development of innovative, compliant and industrially robust products.

We act as a long-term development partner, managing and securing each stage of the medical device development lifecycle with a strong focus on technical excellence, transparency, risk management and close collaboration with customer teams.

Our development process can cover the complete pathway from initial concept to production transfer:

• Product specifications
• Design Inputs
• Product design and engineering
• Prototyping and feasibility
• Design Freeze
• Verification & Validation
• Industrialization
• Production transfer

Quality and Regulatory Affairs activities are integrated throughout the development process.

Projects are managed using a risk-based approach covering project risks, design risks and manufacturing process risks.

Our multidisciplinary team includes biomedical engineers, mechanical and materials specialists, quality experts, regulatory specialists and operational experts with extensive experience in the development of complex medical devices.

We can support projects involving innovative technologies, demanding technical environments or strict regulatory frameworks including MDR, and FDA requirements.

ORIOS places particular emphasis on transparency and project control.

Our customers benefit from:

• Clear project milestones
• Realistic budget and schedule management
• Regular project reviews
• Early identification of technical and regulatory risks
• Defined mitigation actions
• Traceable and documented deliverables
• Technical documentation supporting regulatory submissions

Our development philosophy is based on co-construction with the customer.

Strategic workshops can be organized to refine user needs and product specifications, assess technical options and validate major design orientations.

Iterative prototyping allows concepts to be evaluated and optimized progressively before design freeze. Customer feedback can therefore be incorporated throughout the development process.

ORIOS has dedicated R&D and testing facilities supporting activities such as:

• 3D printing
• Technical tubing development
• Molding
• Medical device assembly
• Mechanical testing
• Environmental testing
• Anatomical models and simulated-use testing
• Product characterization

Development projects can then transition into our ISO 7 manufacturing environment for process development, equipment qualification, IQ/OQ/PQ activities, industrialization and production transfer.

This integrated approach creates continuity between R&D, testing, industrialization and manufacturing.

Our objective is not simply to develop a prototype, but to develop a medical device that can ultimately be manufactured in a controlled, reproducible and scalable way.

We are looking to meet medical device manufacturers, start-ups and technology companies seeking an experienced development partner capable of supporting projects from initial concept through V&V, industrialization and production transfer.