Some of the hot topics
Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or
software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.
Get to know the Trainer
Currently the Director at Compliant Medical Devices Ltd. We are a medical device consultancy company who specialise in the European and Saudi Regulations. I started my professional life as an electrical engineer and had a lot of fun working off-shore and in dozens of different factories as part of a specialist electrical company. I went back to school at Brunel University to play with much lower voltages and completed my Masters in silicon design. I remained in engineering and expanded into mechanical, pneumatic and software design. In 2005 I joined a small company designing anaesthetic equipment targeted at developing countries. These products are now sold in over 40 countries worldwide. I joined a Notified Body as a Technical Expert in 2011 and spent more than six years auditing and teaching all over the world. In 2017 I moved into consultancy where I enjoy doing much the same, supporting manufacturers as well as Notified Bodies and a Competent Authority.
Feel free to suggest the topics that you would like to learn about at
our Regulatory and quality requirements for the design and development of Medical Device Software In-house Training.
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Who should attend?
Those who are involved in any of the following:
• Writing software for Medical Devices or writing software as a Medical Device
• Implementing the EU Medical Device Regulation in their organisation
• Writing technical files or quality systems for the EU Medical Device Regulation
• Quality Engineers or Regulatory Affairs professionals
