Implementation of QMS in compliance with ISO13485/21CFR820/MDR/MDSAP

During this training, you will learn how to:

• Create a QMS implementation plan
• What is a Quality Manual and Quality Policy
• Establishment of QMS procedures – which procedures are mandatory
• Risk-based approach to QMS processes

Specific QMS training

• Supplier evaluation and management
• Effective Corrective Action
• Other custom training as required

Product-specific standards

• Application of Risk Management – ISO 14971
• Medical device software – Software life cycle processes – IEC 62304

Regulatory Training

• Application of EU MDR – a creation of the Technical File

Internal Auditor course for ISO 13485/MDSAP

During this course, you will learn:

• Creation of internal audit schedule
• Internal audit process and implementation for compliance purposes
• Audit Report – Report writing + information that must be included in the audit report
• Response and closeout of non-conformances