The TGA have strict regulations for medical devices.
Requirements continue to evolve as advancements in technology increase the complexity of medical devices.
Now is the time to strengthen your knowledge of best practice to ensure your research with medical devices leads to excellent science and reduced risk.
GCP for Devices is an expert-led workshop designed to provide you with valuable guidance on how to develop quality clinical trial design and operations related to your medical devices.
You will benefit by learning how to:
- Distinguish between what is and isn’t a medical device
- Ensure the medical devices in your work are safe and effective
- Have the most up to date understanding of laws and regulations that apply to your work
- Identify the essential documents required to begin a medical device clinical investigation
- Define what is meant by Good Clinical Practice (GCP) with reference to ISO 14155: 2020 and the laws and guidelines that govern the conduct of research
- Enhance your science and data quality, and support the safety of participants
Our facilitator, Dr Mark Flynn is a highly experienced MedTech clinical leader and strategist, particularly in identifying and solving the wicked challenges in healthcare.
He has launched over 20 medical devices for millions of people globally, and has worked in senior executive leadership positions in Australia, Europe, USA, China, and Latin America. He has developed his strategy to deliver clinical trials meeting regulatory requirements while mixing in pragmatism to deliver marketing and reimbursement outcomes at the same time.
What are people like you are saying about this workshop?
- “Thanks for sharing your knowledge and expertise! I had reservations about attending without having much experience with medical device use, but the information presented was accessible and interesting. The anecdotal stories throughout also assisted in making some of the conceptual information more tangible. I really enjoyed the session and found real value in attending.”
Alison Harwood, HREC Officer, University of Adelaide
- “This workshop was exactly what I needed. It reinforced and explained things I already knew and opened my eyes to areas that I need to know more about. [The facilitator] was excellent, personable, and engaging and provided practical examples and anecdotes from real world experience which helped me relate my situation to the GCP principles.”
Julia, Wunderlich, Senior Clinical Research Fellow, Bionics Institute
- “I enjoyed the interactivity of the workshop; it was very engaging. The presenter welcomed questions and answered all questions comprehensively and with great clarity. I would recommend GCP for Medical Devices as a great workshop in the pretrial planning phase for sponsors/CROs/start up teams, and investigators looking to initiate their own trials.”
Clinical Trial Coordinator, Lions Eye Institute
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