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Mastering medical device quality management: regulations, best practices and avoiding common pitfalls
The regulatory landscape for medical device manufacturers is challenging and so are the requirements for quality management systems.
Join Karandeep Singh Badwal, quality and regulatory expert, in Ideagen’s next webinar where we discuss upcoming regulatory changes and how to make the best use of your quality management system.
In this webinar, Karandeep will provide an overview of the regulatory landscape and upcoming regulatory changes affecting medical device manufacturers and their quality management. Karandeep will also look at the benefits, pitfalls and best practices of using quality management systems for class I, II and III medical devices, providing practical examples on how to conduct a CAPA process.
Key takeaways:
- Overview of the changing regulatory landscape for medical devices with a focus on the EU MDR
- Benefits and best practices when implementing a Quality Management System in your organization
- Pitfalls to look out for when implementing a quality management system for medical devices (for medical device manufacturers of class I, II, and III devices).
- How to conduct a CAPA process from start to finish
- The importance and challenge of software validation
Karandeep is a highly skilled quality and regulatory expert with extensive experience in developing and implementing effective quality management systems (QMS) for medical device companies and UK, EU and USA regulations with a track record of ensuring compliance with regulatory requirements.
Karandeep's contributions to the field have been widely recognized, including by the Chartered Quality Institute/International Register of Certificated Auditors (CQI/IRCA). His expertise and insights have also been published in prestigious journals, such as the British Journal of Hospital Medicine.
With his extensive knowledge and experience, Karandeep is committed to helping medical device companies achieve and maintain high standards of quality and regulatory compliance, while driving innovation and delivering value to patients and healthcare providers alike.