Essential knowledge for medical device manufacturers

Delivered by the experienced team of quality and GMP compliance consultants from SeerPharma, this course is intended for Victorian medical device, medtech and healthtech organisations planning to provide medical devices and related services that consistently meet customer and applicable regulatory requirements of ISO 13485.

Time: 9am–5pm, April 8th, 9th, 11th and 12th (participants to attend all four days)

Location: Superfloor meeting rooms, Melbourne Connect, University of Melbourne

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Description

Your organisation may be involved in one or more medical device life-cycle stages such as design and development, production, storage and distribution, installation, servicing or associated activities (e.g. technical support). ISO 13485 can also be used by suppliers that provide products and/or services to organisations working in these stages.

Participants will gain knowledge and learn process steps to facilitate the implementation of an effective QMS aligned with or certified to ISO 13485:2016.

Applying ISO 13485 helps ensure that businesses deliver consistent good-quality products and services, ultimately improving customer satisfaction and contributing to commercial success.

Course 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 (ISO 14971)
  • 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

Format and Course Length

Delivery will be a mix of theory and interactive case studies and workshops to accelerate your learning with practical skills. Delivery will run over four days (Monday, Tuesday, Thursday & Friday) with group participation exercises and periodic breaks to keep you engaged.