Your computerized Medical Device is 5 years old, outdated and possibly evil

by KVALITO Consulting | Jan 19, 2017 | SMART Life Science

Do you remember the hacked Hospira infusion pump in 2015, which was a big story in the news and forced an FDA product recall? A laptop with applicable software was connected to the maintenance port, which was an Ethernet Network port, of this pump and the hacker got...

eMDR (Electronic Medical Device Reporting)

by KVALITO Consulting | Feb 26, 2016 | SMART Life Science

Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010), which demands registration of any medical devices, which meets the definition of a medical device before starting selling it. It states that...

The Medical Internet of Things Is Here and It Must Be Secured

by KVALITO Consulting | Jan 21, 2016 | SMART Life Science

Security is like the brakes in your car. It slows you down, but it also makes it possible for you to go a lot faster. (Gary Hinson) On the Chaos Communication Congress in December 2015 in Hamburg, Germany, there was a talk about medical devices with new functions like...

Medical Device Legislation in the European Union – Revision of Current Framework including Unique Device Identification (UDI) Regulation is Coming Soon?

by KVALITO Consulting | Oct 29, 2015 | SMART Life Science

If you place a medical device on the market your company must comply with the relevant legislation and corresponding processes. In order to gain access in Europe your company must follow the current European Commission framework which is composed of three directives:...

Digital Health Compliance

by KVALITO Consulting | Feb 10, 2015 | SMART Life Science

“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You may have heard a friend talk...