Regulatory and quality requirements for the design and development of Medical Device Software In-house Training
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.
Regulatory and quality requirements for the design and development of Medical Device Software In-house Training
EVENT INTRODUCTION
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.
Who should attend?
• 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
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