company-logo

Tag

medical devices

VGBio’s Vitalink: Predictive Analytics for Remote Patient Monitoring

One of the reasons VGBio is one of Pathfinder’s favorite clients is because they show how four of the most powerful technology trends affecting healthcare (body area sensor networks, smartphones, cloud computing and big data/predictive analytics) can be used together to reduce costs and improve outcomes.  VGBio technology enables the daily monitoring of patients with chronic diseases and provides
Read More

Agile in FDA Regulated Medical Software – Functional Testing vs Technical Testing

Testing is a crucial part of all software development. If you don’t believe this you are likely just starting your career or haven’t had to support an application in production with users.  It becomes doubly important in regulated environments like the ones for medical devices. This is because testing for regulated software serves multiple purposes. There is the usual software product development reasons
Read More

Agile and the FDA: Faster, Better Development for Medical Devices

We presented our approach to implementing agile in an FDA regulated environment to a joint meeting of the Chicago Agile Project Management Group and Health 2.0 Group last week. This is based on our experience developing software for medical devices, and focuses on how to get the benefits of agile development while conforming to FDA regulations.
Read More

Agile in FDA Regulated Medical Software – Checklists

Lets be honest: Checklists aren’t the most exciting topic to blog about. However, in the context of regulation they become interesting. Everybody loves checklists and hates them at the same time. It’s really easy to make them and just as easy to forget to use them. Later on, after the emergency and/or reason they were created has subsided, using the checklists becomes a ceremony – something that mus
Read More

Agile in FDA Regulated Medical Software – Have Some Class

The FDA states that a medical device is a product that is used for medical purposes in patients, in diagnosis, therapy, or surgery. As opposed to a pharmaceuticals, who use the body’s metabolism, medical devices act mechanically or chemically. The FDA’s role in this is to assure the safety and effectiveness of devices. Keep this in mind while going through the process (they are not just to make your life
Read More