Please note, this is a four-day course delivered on the 13th, 14th, 16th, and 17th of November with a rest day on the 15th. Participants are to attend all four days.
Sponsored by the Victorian Medtech Skills and Devices Hub (VMH), this four-day course is intended for MedTech and HealthTech organisations involved in one or more medical device life-cycle stages including design and development, production, storage and distribution, installation, servicing and associated activities (e.g. technical support), as well as product and service providers to organisations working in these stages.
A valuable upskilling opportunity for professionals, this course provides participants with the knowledge needed to facilitate the implementation of an effective quality management system aligned with 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 is delivered by the experienced team of quality and GMP compliance consultants from SeerPharma. SeerPharma's range of consulting, training, contract labour, and software solutions have been supporting clients across Asia-Pacific for more than 30 years, offering a wealth of knowledge for course attendees.
Time: 9am to 5pm, November 13th, 14th, 16th, and 17th. Participants to attend all four days.
Location: Superfloor conference rooms, Melbourne Connect, University of Melbourne
- 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