Failed MRA Agreement leaves Swiss and EU MedTech Manufacturers in Disarray

by Lara Bartlett | Aug 9, 2021 | SMART News

Trade barriers ruffle feathers of Swiss and EU MedTech Manufacturers with potentially dire consequences for Patients  Until May 25, 2021, any MedTech goods approved for sale in Switzerland and the EU could be marketed...

What is the Development Lifecycle of a Medical Device?

by Alix Auter | 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....

Medical Devices; US and Chinese legislation

by Alix Auter | 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...

Bite-sized Knowledge: Medical Device Regulation

by Alix Auter | Mar 6, 2020 | SMART Life Science

A 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...

Health Technology Software Quality & Compliance

by Rodrigo Alvarez Sanchez | 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...