Pre-Conference Workshop or Training Day
Saturday, November 2nd, 2019
Delivering a medical device to the market is a complex challenge, where too often the simplest development may transform into an endless resource drain on a medical device team. From identifying the market need to device validation and post-production activities, the checklist of milestones to be accomplished can become daunting.
Overcome the principle challenges faced during and post development of a medical device by utilising the tips and tricks used in real-life examples, to ensure you maintain regulatory compliance and end-user expectations throughout your agile development. Combat challenges in risk management, architectural design, verification and validation, effective documentation and preparing yourself for post-release life, by learning from example and employing methods with peer-proven success.
- Maximise the efficiency of your development activities as per the FDA Design Controls using real-life case studies
- Understand the power of standard operating procedures beyond
- Delivering you medical device is just the beginning: Prepare yourself for post-commercial life by learning from real-life examples
- Benchmark your own practices against the KIRO Link Project