Every company, every software development team works somewhat differently. Each distinct product category involves its own set of development tasks. A “one size fits all” approach to software quality procedures therefore is not useful; software SOPs instead need to be tailored to the team and tasks while fulfilling regulatory expectations. In this guide, you will find questions and suggestions developed to help teams generate their own software SOPs.
Agile 101: Beginning the Agile Journey for Software Design in Healthcare An Introduction to the Principles, Practices, and FDA Compliance
Balanced progress is the hallmark of genuine Agile practices when you remove all the misinformation and poorly executed attempts. Balance in the sense that there is no point writing software faster than we can test it, testing it faster than we can deploy it, or designing it before we can check whether it is really what our customer actually needs and will use. This kind of balance is not merely allowed by FDA, but is in fact more compliant than what most companies do now.
Pharma IQ prepared this Agile Info Pack, the definitive resource for professionals in the agile area. The guide summarizes the key issues related to new agile development in healthcare, changes in clinical evaluations for medical devices and tips on the agile techniques for a project and address the regulatory challenges of developing a medical device.
While establishing design controls and proper documentation can be daunting, this process can have many positive downstream effects. In this podcast Michael Meissner, VP Software R&D and Program Manager, Omnyx LLC (a GE and UPMC joint venture) talks about using Agile methods to ensure successful audits.
Software Development for Medical Devices - Overcoming the Challenges of Compliance, Quality and Cost, An MKS White Paper
This paper reviews some of the key challenges facing the medical device industry, and examines the role that an application lifecycle management (ALM) platform can play in meeting these challenges.
Since there is no margin for error in the software driving these innovative devices, Inomed established extensive processes to ensure software integrity. Such full-lifecycle quality processes are essential for complying with IEC 62304, a "harmonized" medical device software safety standard that has been adopted by the European Union and the United States.