For all training, a certificate of participation will be issued.
We offer the following training courses:
Implementation of QMS in compliance with ISO13485/21CFR820/MDR/MDSAP training
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 training
- 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
For all training, a certificate of participation will be issued.