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SMART Life Science
Good Documentation Practices in Regulated Environments
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Digitalization of Pathology – A New Approach
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...
Medical Devices; US and Chinese legislation
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA...
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....
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...
Bite-sized Knowledge: Medical Device Regulation
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective...