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 medical device manufacturers training at all regulatory, quality and clinical levels. As a leading medical device consultancy with offices in Europe, the United States, and China. Qserve's staff offers years of international experience with both broad and specific expertise for a wide range of medical devices and IVD's

"As a trainer I enjoy and promote the interactions between and learnings of the delegates. In a training group there is so much knowledge and skills available and sharing yours is rewarded by you colleague delegates in multiple! I create a safe and pleasant environment where learnings can be accomplished effectively. I stimulate your curiosity and help you to understand the subject at hand."
Peter Reijntjes, Head of Training

Check our Training flyer or our event page for our open training program 2018-2019

Services

Training opportunities

 

EU Medical Device Regulation training (EU-MDR)

Understanding the landscape of the Medical Device Regulations in Europe (EU MDR), US, China and beyond.  

In Vitro Diagnostics (IVDR)

Learn how to determine the conformity route and the supply chain requirements.  

ISO 13485:2016

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

MDSAP

Learn the MDSAP Fundamentals, such as regulatory audit approach.

Clinical Evaluations

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

ISO 14155 GCP

Practical implementation of the ISO-14155 GCP standard for medical devices. 

CFDA Training

Introduction to Chinese regulatory & regulations overview.

Internal Auditing

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

Risk Management, ISO 14971

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