We provide Eexpert Medical Device and QMS Training Programs -> PSM-ACADEMY

Our training programs are built on extensive practical experience, and we ensure that your personnel not only understand the topics, but they can also apply them effectively in the real-world settings.

Knowledge that drives quality and compliance:

• Tailored training courses to your specific needs
• Practical, Real-World Focus
• Regulatory Expertise
• On-site or Remote Sessions

Our Training Courses include:

• ISO 13485:2016
• Design Control - 21CFR820.30
• MDR, CE Marking & FDA Approval
• Risk Assessment - ISO 14971:2019
• Human Factor Engineering - IEC 62366
• GMP for Medical Devices
• Combination Products
• Good Documentation Practice (GDP) & Good Test Practice (GTP)
• Medical Device Documentation
• Equipment Validation
• Medical Device Sterilisation - technologies (EO, Gamma, E-beam, X-ray), validation approach, challenges, trends, regulatory expectation
• Introduction to MedTech for Start-Ups