Medical Device and Health Software - Regulation and Standards

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IET Birmingham: Austin Court


B1 2NP

United Kingdom

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Rejection of regulatory submissions for the approval for sale of a medical device causes delayed product launch, lost revenues, increased costs and damaged reputation. For devices containing software we can help minimise the risk of rejected submissions through our training solutions which detail best practice software development for medical devices. Frequently asked questions often relate to the amount of detail required in, for example, software requirements specifications, detailed design documents and hazard analyses tables - our cost-effective training programmes help you get the balance right and achieve better compliance and faster time to market.

Changing Regulations

The Council of the European Union’s Permanent Representatives Committee endorsed on 15 June 2016 the agreement reached with the European Parliament on the proposed Medical Device Regulation (MDR).

The most significant change for software systems can be found in Rule 10a, intended for application to stand alone software that fulfils the definition of a medical device. Rule 10a states:

“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, is in class IIa, except if such decisions have an impact that may directly or indirectly cause:

the death or an irreversible deterioration of the state of health, in which case it is in class III;

a serious deterioration of the state of health or a surgical intervention, in which case it is in class IIb.

Software intended to monitor physiological processes is in class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb.

All other software is in class I.

The essential requirements have been updated for certain software related aspects. The requirements detailed in 14.2 replaces 12.1. of the old medical device directive whilst some new requirements have been introduced in the following areas:

IT environment (11.2)

Interoperability (11.5)

Cybersecurity (14.2)

Mobile platforms (14.3)

IT network and IT security (14.3a)

What you will learn:

Medical Device Regulation in the EU and US applies to software in medical devices and to stand alone software used in health applications such as physiological monitoring and diagnostic support. We will cover the following standards: IEC62304; IEC82304; ISO14971; IEC62366 and Software As A Service, Mobile Devices, Tele-Medicine and Software Only Systems in addition to conventional medical devices.

Software Development

  • Development Planning

  • Requirements Analysis

  • Architectural Design

  • Detailed Design

  • Coding and Verification

  • Integration and Integration Testing

  • Software System Testing

  • Software Release

Software Maintenance

  • Maintenance Planning

  • Problem and Modification Analysis

  • Modification Implementation

  • Risk Management of Software Changes

  • Change Control

  • Configuration Management

Risk Management

  • Safety Risk Classification

  • Risk Management Planning

  • Risk Identification

  • Risk Analysis

  • Risk Evaluation

  • Risk Control

  • Residual Risk Analysis

  • Risk Benefit Analysis

Who should attend

Medical Device Manufacturers: R&D Managers, Software Managers, Project Managers, Software Architects and Engineers.


Our location in the heart of the city means that IET Birmingham: Austin Court is fully accessible by all major transport links across the Midlands and is conveniently located seconds from the National Indoor Arena.

About us

We bring significant expertise in medical device software – both from a regulatory standpoint and from a technical perspective. Our experience includes some of the most complex and most safety critical systems. This includes radiation oncology, diagnostic imaging, dialysis systems, implantable devices, vascular therapy, surgical systems, treatment planning software, in-vitro diagnostics, advanced wound therapy, pressure area care, mobile medical applications and drug delivery. We currently have access to specialists who work with EU Notified Bodies as software subject matter experts and have held seats on IEC committees responsible for the creation of standards such as EN62304 and ISO14971.

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IET Birmingham: Austin Court


B1 2NP

United Kingdom

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