Main Qualifications are:

• Auditor according to ISO 13485:2007 and MDR
• Risk management according to ISO 14971:2012 and 2019
• Usability according to IEC 62366
• Cybersecurity according to IEC_81001-5-1
• CAPA management
• Product and process FMEA
• Qualification and validation of manufacturing processes
• Expertise in national and international standards
• Certification/Approval according to MDR, 510(k)
• Six Sigma Black Belt
• Knowledge of sterilisation processes for medical devices
• Knowledge of biocompatibility for medical applications