Outsourcing

GMP Services. QA and RA Projects.

Capamed offers a number of services of the highest quality available. In addition, we customize our services to suit your specific needs and objectives.

Our services include:

  • Quality Management:
    • Creation of procedures and complete quality management systems
    • Optimization of quality-related business processes
    • Training and Seminars
    • Outsourcing of internal audit or supplier audits
    • Audit preparation for inspections by the FDA or your Notified Body
  • Product Development and Market Approval:
    • Optimization of product development
    • Compliance with standards, e.g. IEC 62304 Software, IEC 62366 Usability
    • Risk management for product development, engineering and manufacturing processes, compliant wirh ISO 14971
    • Preparation and review of product documentation (Device Master Record and EU Technical File)
    • Preparation of 510k applications for product approval of medical devices at the FDA
    • Establishment Registration and U.S. Agent
    • EU Authorized Representative
  • GMP Projects:
    • Validation of manufacturing and cleaning processes
    • Software validation
    • Validation according to 21 CFR part 11
    • Qualification of systems and equipment
    • Project management for a variety of GMP projects