Training Academy

Medical Device Regulatory Training

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.  

 

TRAINING

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.

TRAINING

All training opportunities

EU MDR training

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

In-Vitro Diagnostics training

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

ISO 13485:2016 training

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

MDSAP training

Learn the MDSAP Fundamentals, such as regulatory audit approach.

Clinical Evaluations training

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

ISO 14155 GCP training

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

NMPA training

Get an introduction to Chinese regulatory and a regulations overview.

Internal Auditing

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

Risk Management training

Our ISO 14971 training helps you understand the process and importance of risk management during the life cycle of your device.  

How can we help you? Contact us