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Theranostics: The Future of Precision Medicine
The term "theranostics" is a combination of "therapy" and "diagnostics"; it is an emerging field that combines into a...
HR CIRCLE TAO OF PEAK PERFORMANCE
Are you ready to take your professional journey to the next level? We’re thrilled to announce we’re collaborating with...
Event Update! CoP PM trifft auf aufstrebende Leader & Studenten im Bau 2 Roche in Basel
Beim CoP PM-Event im Roche Bau 2, dem höchsten Gebäude der Schweiz (stolze 205 Meter), kam eine familiäre Atmosphäre...
Risk Management for Medical Devices: ISO 14971:2019
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment....
Working from home is becoming the new normal for everyone
"Technology now allows people to connect anytime, anywhere, to anyone in the world, from almost any device. This is...
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...
Stay Safe and Healthy
Even in the current situation, KVALITO Consulting Group is actively contributing to the economy, continuing to turn...








