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How is a system validated?

How is a system validated?

Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary.  AVerification: Confirmation, through the provision of objective evidence, that specified requirements have been...

What is a software product framework?

What is a software product framework?

A software product framework is a set of software units assembled in a software item. The collective software items form the software system. The software system, together with the packaging and the instruction for use, shape the software...

Usability and Labelling

Usability and Labelling

What is usability ?   The new Regulation, MDR, strengthens the rules regarding labelling and usability.   Usability is the characteristic of the user interface that facilitates use and...

Electrical safety and EMC 60601

Electrical safety and EMC 60601

IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for basic safety and essential performance. Collateral standards apply the 60601-1-3 standard states for radiation...

How to conduct a Software Risk Assessment

How to conduct a Software Risk Assessment

First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs. Risks combine the severity of harm (S) and the...

Digitalization of Pathology – A New Approach

Digitalization of Pathology – A New Approach

Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and improve the workflow in pathology laboratories. It focused on data management based on information generated from digitized...

CDRH Validation vs. CSV

CDRH Validation vs. CSV

“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or...

Medical Devices; US and Chinese legislation

Medical Devices; US and Chinese legislation

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...

Vigilance from a Medical Device perspective

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 (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an...

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