Whitepapers

ITK Engineering Develops IEC 62304: Compliant Controller for Dental Drill Motor with Model-Based Design

ITK Engineering Develops IEC 62304: Compliant Controller for Dental Drill Motor with Model-Based Design

Sensorless brushless DC (BLDC) motors are well-suited for use in dental drills. They operate with less abrasion than brushed motors, and are more reliable, quieter, and easier to maintain and sterilize. Compared with BLDC motors with sensors, sensorless BLDC motors are less expensive and more compact.

Thoughts for Developing Software Quality Procedures

Thoughts for Developing Software Quality Procedures

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.

Agile Software Info Pack

Agile Software Info Pack

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.

Software Development for Medical Devices - Overcoming the Challenges of Compliance, Quality and Cost, An MKS White Paper

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.

CASE STUDY: Inomed Streamlines IEC 62304 Medical Device Software Certification

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.

Software Design for Medical Devices Investment Activity

Software Design for Medical Devices Investment Activity

In a recent report, Pharma IQ discovered a selection of investment behaviours regarding medical device software design. This year, we ask a selection of experts to provide their analysis on those findings and their projections on how the industry will behave in the years ahead.
Software for Medical Devices Cyber Security

Software for Medical Devices Cyber Security

Ahead of the 2017 Software for Medical Devices conference, Pharma IQ brings you this whitepaper looking at what you need to know in regards to software cyber security for medical devices.