12 - 13 February, 2019 | Meliá, Berlin, Germany

Ramon Alonso


Software Development Manager
Kiro Grifols


9:30 AM Map the Key Challenges During the Development Cycle to Decrease Your Time to Market

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.

Session Objectives:
  • 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 


Check out the incredible speaker line-up to see who will be joining Ramon.

Download The Latest Agenda