Medical Device Software Development
21 March 2012
Medical technologies are highly regulated in all major countries and a good understanding is needed of the regulatory framework for each of the countries where product introductions are planned. Regulatory requirements will have a direct impact on the development process and failure to get it right the first time can have disastrous consequences for your return on investment. In fact, the estimated life of many medical devices ranges from about 18 months to 2 years, while some products requiring large capital investment or long-term clinical data for market penetration have longer life cycles.
Why should you care about Medical Device Software Development?
The FDA and notified bodies are putting medical device software under increased scrutiny. The number of product recalls associated with medical software more than doubled from 10% to 21% over the decade ending in 2006. Therefore, software development must be done in accordance with the state of the art development processes.
Software development at Sagentia is conducted according to IEC 62304:2006, which is the state of the art for European certifications and recognised by the FDA. In addition, our projects are carried out under the framework of a robust product development process which is certified to ISO9001:2008 standards and accredited to ISO 13485:2012, the medical device quality management standard.
The FDA states that “Conformity with IEC 62304 will create a framework for the software life cycle processes with activities and tasks. These processes, activities and tasks are necessary for the safe design and maintenance of medical device software. Compliance with this standard provides a development process that should consistently produce high quality, safer medical device software. This standard identifies the minimum activities and tasks that need to be accomplished to provide confidence that the software has been developed in a manner that is likely to produce highly reliable and safe software products. Conformance to this standard provides evidence that a software development process is in place and fulfills the document recommendation of the Software Development Environment Description section of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".”
Directive 2007/47/EC states that “(20) Taking account of the growing importance of software in the field of medical devices, be it stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement”.
Dr Paulo Pinheiro
See below for case studies highlighting Sagentia's expertise in software development.