by Lara Bartlett | Jul 9, 2020 | SMART Life Science
What is the development lifecycle of a Medical Device? Figure 1: Medical Device development lifecycle. Adapted from ISO 13485:2016. Copyright 2020, Kvalito Consulting Group. First and foremost, the user requirements need to be defined by the organization....
by Lara Bartlett | Apr 17, 2020 | SMART Life Science
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group. How to classify a device under US regulation? Picture from...
by Lara Bartlett | Mar 6, 2020 | SMART Life Science
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure 1: Overview of the difference...
by Lara Bartlett | Feb 11, 2020 | SMART Life Science
“Once a new technology rolls over you, if you’re not part of the steamroller, you’re part of the road.” Stewart Brand Health Technology is defined by the World Health Organization (WHO) as “the application of organized knowledge and skills in the form of...
