Index What is cloud computing? Background on cloud computing Why has it emerged for companies Challenges of...
INSIGHTS
SMART events
SMART news
SMART Life Science
SMART Career
SMART Corporate Citizenship and Social Responsibility
SMART Life Science
Nuclear Medicine in the Treatment of Cancer
Index Acknowledgements Introduction Theory behind Radiation & Radioactivity Radiopharmaceuticals – What, Why &...
Data Protection Day, Data Privacy Day: 28 January 2023
"Privacy is Paradise." — Holly Hunter.On January 28th 1981, the Council of Europe adopted Convention 108 as its first...
Vigilance from a Medical Device Perspective
What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions...
Classification of Software as a Medical device under Medical Device Regulation (European Union)
Classification of software as a Medical device under Medical Device Regulation (European...
Overview of guidance and information published by the EMA and the FDA concerning the current COVID-19 epidemy
Temporary authorizations issued in response to the COVID-19 pandemic FDA enforces policy for infusion pumps and...
Medical Devices under the EU´s Changing Regulatory Framework
Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a...
What are the principal differences between the conformity assessment process of a medical device in the USA and in the European Union?
Figure 1: Comparison of European and US Conformity Assessment process of Medical Devices. Adapted from European...
Special circumstances require special measures FDA announced temporary changes related to onsite audits requirements
In response to the global pandemic of COVID-19, the FDA temporarily does not enforce supplier verification onsite...
Health Technology Software Quality & Compliance
“Once a new technology rolls over you, if you're not part of the steamroller, you're part of the road.”—Stewart Brand...
LabWare Vs LabVantage: What LIMS can best fit your customer needs?
LabWare Vs LabVantage: What LIMS can best fit your customer needs? “The important thing is not your process. The...
Manual vs. Automated Testing
“I don't care if it works on your machine! We are not shipping your machine!” — Vidiu Platon. ...