Expertise field

Practical Regulatory, Quality and Clinical training in small groups

 

A stimulating interactive training environment focused on all compliance areas of the medical device industry with pragmatic in-house training possibilities, based on your wishes.

Our method

Services

What we can do for you?

 

Medical Device Regulation

Understanding the landscape of the Medical Device Regulations in Europe, US, China and beyond.  

Internal Auditing

Learn how to monitor compliance with standards as a real auditor and implement improvements.   

ISO 13485:2016

Get insight in the scope of the international QMS standards and link them to business processes. 

Risk Management, ISO 14971

Understand the process and importance of risk management during life cycle of your device.  

Medical Software

Learn the software requirements, risk assessment in regard to software verification / validation.

Electrical Safety, IEC60601

Gain awareness of the electrical safety and essential performance compliance process.

CAPA & Complaints

Learn to manage complaints, determine reportable incidents and manage your CAPA system.  

Clinical Evaluations

Gain understanding to write and maintain Clinical Evaluation Reports and define procedures.

QSR 21 CFR 820

Get insight in the scope of the international QMS standards and link them to business processes. 

More information about one of our training services?

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