Expertise field

Practical Regulatory, Quality and Clinical training

 

As a regulatory professional, you play an important role in the product life cycle within your organization. Medical Device Regulations in many countries show increasing complexity and require manufacturers to increase the level of regulatory knowledge. So, you need to provide your organization with more and higher quality regulatory knowledge.  

Why choose Qserve as your regulatory trainer?

Qserve offers all stakeholders in the medical device regulatory, clinical and quality industry specialized training to strengthen their team and bring their knowledge, competences and skills to a higher level.

 

Services

Training opportunities

 

EU Medical Device Regulation training

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.

Clinical Evaluations

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

More information about one of our training services?

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