Qserve offers medical device manufacturers training on all regulatory levels, stay up to date and strengthen your team.
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.
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.
Understanding the landscape of the Medical Device Regulations in Europe, US, China and beyond.
Learn how to determine the conformity route and the supply chain requirements.
Get insight in the scope of the international QMS standards and link them to business processes.
Learn the MDSAP Fundamentals, such as regulatory audit approach.
Gain understanding to write and maintain Clinical Evaluation Reports and define procedures.
Practical implementation of the ISO-14155 GCP standard for medical devices.
Learn how to monitor compliance with standards as a real auditor and implement improvements.
Understand the process and importance of risk management during life cycle of your device.
Gain awareness of the electrical safety and essential performance compliance process.
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