HEALTHCARE PRODUCT LIFECYCLE
HEALTHCARE PRODUCT LIFECYCLE
The ICARE Group is there to serve its clients at every stage of the healthcare product lifecycle :
Concept & FEASIBILITY STUDY
- Initial evaluation of a possible product development,
- Market study,
- Drafting of regulatory & technical specifications,
- Initial risk analysis,
- Classification of the product according to its use.
- Improving production & minimizing risks
- Ensuring compliance with standards & regulations
CHOICE OF MANUFACTURING PROCESSES
- Definition of the design in accordance with the client’s needs and the regulatory requirements,
- Development of the design of the products and the manufacturing processes, checks and validations,
- Preliminary tests / characterization of the product,
- Pre-clinical evaluation of the product,
- Clinical evaluation of the product.
- Controlling the subcontracting of the product
MARKETING AUTHORIZATION
- Final validation of the manufacturing process and preparation of the marketing of the product,
- Monitoring,
- Support in drafting of applications,
- Application for reimbursement.
- Controlling all project development phases
Production & distribution
- Product launch,
- Project start-up,
- Production unit,
- Staff training,
- Control of equipment and processes,
- Release tests,
- Start of production,
- Qualification & Validation of equipment and processes.
- Setting up a monitoring strategy via tests to be deployed throughout the period of marketing of the product
MONITORING, ANALYSIS & CONTROL
- Post-marketing monitoring plan,
- Routine tests,
- Continuous improvement of process & product,
- Production control throughout the lifetime of the product,
- 360° project control,
- Qualification & Validation of equipment and processes.
- Ensuring & maintaining quality & compliance with standards throughout the period of marketing of the product
- Gaining in autonomy & acquiring skills