Training
We bring the knowledge to you and turn you into “qualified personnel”. We have extensive expertise in the field of medical technology and are happy to pass on this knowledge.
MEDTECH360 offers you customized training in various areas
Contents:
- Regulatory framework
- Authorities
- Economic areas
- Requirements and restrictions for a medical device
- (harmonized) standards
- Conformity assessment
- procedures Basic safety and performance requirements
- Intended purpose
- Classification of medical devic
To the training request
The training takes place in the form of a workshop. Basic content and procedures for setting up a QM system are shown. Special emphasis is placed on adapting the QM system to the company structure and not vice versa.
Contents:
- Strategies for installing a QM system (prioritization of processes)
- Basics of quality management (control of documents, management tasks, product processes, improvement processes)
- Structure and structuring of a quality management manual
To the training request
Content:
- General requirements for risk management
- Preparation of a risk management plan
- Moderated performance of risk analyses for your product(s)
- Risk assessment
- Overall residual risk
- Risk management report
To the training request
The training courses take place on site or virtually.
Contact us at any time and we will provide you with a non-binding quote.