Icare

HEALTHCARE PRODUCT LIFECYCLE

HEALTHCARE PRODUCT LIFECYCLE

The ICARE Group is there to serve its clients at every stage of the healthcare product lifecycle : 

Concept & étude de faisabilité
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
Choix des process de fabrication
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
Autorisation de mise sur le marché
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
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
Suivi, analyse & contrôle
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
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