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