Medical Device

Semcon Medical Life Science can help you with a wide range of services in the field of medical devices.

Our expertise includes:

• Product development – design control
• Production efficiency and development
• Quality management systems
  – quality assurance
  – quality control
  – risk management
  – verification/ validation
• Gap analysis – regulatory compliance
• On-site and supplier audits
• Value chain analysis
• CAPA – Corrective and preventive actions
  – improvement process
  – solve inspection findings – N.B/FDA/Competent authority
• Training – GMP, ISO 13485/ 9001, MDD, QSR, Part 11