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Training & Support 2018-01-05T17:19:58+00:00

Personalized Regulatory and Quality Training & Support

Our regulatory and quality affairs training service helps you to fill the void between the curriculum of a theoretical education and the practical demands of adhering to medical device regulations and validation processes.

Learn how to design and develop medical devices to international quality standards such as ISO 13485 or GDPMD, how to meet and keep ahead of EU medical device directive regulatory requirements, and gain knowledge of the CE Marking process through our bespoke training programs. We also offer a wide range of specialist courses to meet your specific needs as a medical device company.

“Our specialized training will supplement your existing quality and regulatory knowledge with real world experience and advice.

Training Topics

  • How to implement a GDPMD Regulatory Compliance System?
  • How to implement an ISO 13485 Quality Management System?
  • How to implement Risk Management for medical devices?
  • How to compile a technical file for CE Marking?
  • How to comply with FDA Quality System Regulations?
  • Good Manufacturing Practices (GMP)

Our personalized training will enable you to quickly adapt your present technical knowledge to real world examples and events. You’ll learn how to put your skills to work.

Do not worry if your have no prior background in the topics that we train, as we will take the extra time to help you absorb the material in a timely and efficient manner.

Contact our staff to learn more on how we can help to accelerate your knowledge of medical device regulation and validation process and procedures.

Personalized Training & Support – FAQ

Andaman Medical provides a comprehensive range of regulatory and quality affairs training services at our offices in Malaysia and Singapore. We also offer tailor-made specific courses, which we can run at client premises.

Yes. Companies registered with the HRD Council in Malaysia can apply to claim the course fees (amount to be approved by HRD Council). *Human Resources Development Fund

Because our clients all have very specific needs, Andaman Medical will design a unique training course to cover each aspect of the medical device lifecycle. Contact us to find out more about our customized medical device quality and regulatory training solutions.