We are Committed to Sharing our Experience and Knowledge of Medical Devices
Training
Training tailored to your specific needs is offered, designed to develop team skills and maximize their performance.
Each of the training sessions can be customized upon request.
They can be conducted in person at your company or remotely, according to your preferences.
Preparing Technical Documentation in Accordance with the European Regulation 2017/745
Preparing Technical Documentation in Accordance with the European Regulation 2017/745
- Identify the elements of the technical documentation needed for the conformity of medical devices to the regulation requirements.
- Learn best practices and the expectations of notified bodies when preparing technical documentation.
1 day
Change Control
Change Control
- Understand the regulatory and standards requirements for changes to a medical device.
- Acquire a methodology for managing changes and ensuring the traceability of elements.
1 day
Design Control
Design Control
- Understand the regulatory and standards requirements
- Understand the key steps of the design control process
- Acquire a methodology for design control
- Learn how to prepare a design dossier / DHF
1 day
Manufacturing Process Validation
Manufacturing Process Validation
- Understand regulatory and standards requirements
- Acquire the applicable methodology (IQ, OQ, PQ)
- Understand the validation sequence and process control
- Define a validation plan and understand the contents of a DMR
2 days
Understanding and Applying the Requirements of the European Regulation 2017/745 on Medical Devices
Understanding and Applying the Requirements of the European Regulation 2017/745 on Medical Devices
Identify and understand the requirements of the European Regulation on medical devices (2017/745) in order to apply them to your organization and medical devices.
1.5 days
Understanding the Requirements of MDSAP Countries and Preparing for an MDSAP Audit
Understanding the Requirements of MDSAP Countries and Preparing for an MDSAP Audit
- Understand the regulatory requirements of the countries in the MDSAP program.
- Prepare for an MDSAP audit.
2 days
