• by Signup Training

Medical devices like blood pressure cuffs, dosimeters, pacemakers, hospital beds and many others have software that regulate their functionality so as to ensure safety and good performance. However, in the year 2012-13 many medical devices were recalled due to faulty performance. This lead to the Implementation of IEC 62304

What is IEC 62304?

IEC 62304 is the international standard that defines software development lifecycle for medical devices. The standard was developed from the perspective that product testing shouldn’t be the only methodology for safety when software is involved. With the implementation of this standard, it requires that all aspects of the device be checked; configuration, risk management, development, problem resolution and maintenance. This provides a common framework that can be used by medical device manufacturers to develop software.

Complying with the medical device safety standard is important for all medical device software developers. Below we share some compliance tips for all Medical Device Software Developers:

1. Get acceptance from the international medical community

Complying with the IEC 62304 standard for medical device software not only ensure recognition from the international community but it automatically satisfies the requirements of regional standards as well. Having an IEC 62304 standard satisfies key requirements in the Medical Devices Directive of the EU and in the US, the FDA accepts this standard as proof that the devices follows all regulatory requirements.

2.  Use software development tools

Having well-documented processes is a big step towards compliance, and having a software development tool that aids this process can be very useful. Some of the processes involved in medical device manufacturing includes development planning, requirement analysis, architectural design, detail design, unit implementation, integration, system testing and release. A software development tool can really accelerate progress and ensure proper documentation as well.

3. Use software maintenance process tools

The IEC 62304 safety standard describes the method to ensure proper software maintenance processes. This includes establishing a software maintenance plan, problem and modification analysis and implementation of those modifications. Taking inputs and resolving issues is crucial in the maintenance phase of the medical device. With the use of the right software, medical devices manufacturers will be able to identify changes across the medical device lifecycle.

4. Have a software risk management process

The IEC 62304 clears defines a risk management process. This involves analysis of software contributing to hazardous situation, risk control measures, verification of risk control measures and risk management of software changes. It’s important to use the right software to track movement from a hazardous situation to a risk control measure.

These are just some of the measures where the IEC 62304 has helped bring in more compliance.

Join our webinar on Understanding Medical Device Software / IEC 62304 Compliance to stay updated on all the compliance