SeerPharma – MTP Connect REDI Subsidised ISO13485 Training Course: Melbourne

Posted: 28 July 2022

Upcoming workshop on ISO13485

15-19 August at the View Hotel in St Kilda

SeerPharma is running this workshop as part of MTP Connect’s nation-building REDI Initiative.

This workshop is a valuable opportunity for BioMelbourne Network members. It is heavily subsidised by MTP Connect and is designed to assist professionals seeking to better understand and appreciate their Quality Management requirements.

This course is for manufacturers and companies intending to manufacture medical devices and is their first step on the path to ISO 13485:2016 certification. It is suitable for manufacturers and companies with existing quality system certifications (such as ISO 9001:2015) as well as those with no existing certifications. It is also applicable to staff in companies with existing ISO 13485:2016 certification who have a role in implementing the system.

Participants will gain knowledge and learn process steps to enable them to effectively implement a quality management system and to meet the requirements for ISO 13485:2016 certification.

Content

  • Overview of Quality Management Systems, particularly ISO 13485:2016
  • Benefits of quality system certification and of alignment
  • Purpose, structure and requirements of ISO 13485:2016
    • Quality Risk Management for medical devices
    • Management Responsibility
    • Resource Management
    • Product realization
    • Measurement, Analysis and Improvement
  • Overview of application process for ISO 13485:2016
  • Development of documentation required for ISO 13485:2016
  • Preparation for applying for ISO 13485:2016

Further information is available here.

Full course outline that will be covered over the four days is available here.

This workshop would be of benefit to companies involved with diagnostics/medical devices in Victoria,

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