With more regulatory guidance for software and apps becoming available, it is imperative you understand how to classify your product so that you can apply the regulatory guidelines which concern it.
Build upon the knowledge of the Medical Device Regulation with two online courses designed to build your knowledge in software and apps:
1. Navigating the Regulations for Health Apps and Medical Device Software
2. Applying the Regulations for Health Apps and Medical Device Software
Led by Koen Cobbaert, learn from a regulatory expert in the field. Koen has co-written MEDDEV 2.1/6, MDCG 2011 - 11 and published guidance on the use of IEC 62304. Koen has extensive knowledge on this area. With MDTI's online academies, you will obtain direct contact with Koen ensuring any queries you have relating to the course material will be addressed throughout the course.
Purchase a place on both online academies and get 20% off, saving you a total of £258 + VAT. Attending both courses will provide you with a complete understanding of the regulatory requirements for health apps, how to apply them to your product and how to ensure patient safety.
Gain an in-depth understanding of the regulations and guidance surrounding health apps and medical device software. Designed for professionals working in the development and regulatory aspects of medical software and apps, ensure you are aware of your obligation under the Medical Device Regulation and how to utilise the guidance available to you.
Develop your knowledge of the methodologies available to identify and manage risk associated with your software, to ensure you are complying with the general safety and performance requirements (GSPR) pertaining to safety and security.
Further your knowledge of the Medical Device Regulation so you can maintain compliance with the usability and effectiveness guidelines surrounding medical device apps and software. Identify strategies to tackle the guidelines, outlined in the MDR, referring to conducting robust clinical investigations, evaluations and post-market vigilance reporting.