A regulation shall be applied in its integrality in all the European Union. Unless a directive sets out an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure...
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Alix Auter
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?
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
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 establishes effectiveness, efficiency and user...
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
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...
What is Software of an Unknown Provenance known as SOUP?
International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a...
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...
Sterilization Processes for Medical Devices
What kind of sterilization methods can be used for a medical device? There are different methods for the sterilization of medical devices, using gas and steam or radiation. 1. Radiation...
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
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...
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. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device 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 (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an...
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 Union) The first step is to determine whether your software is a Medical Device. How do...
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 accessories during the coronavirus disease 2019 To help facilitate the availability of infusion pumps, the FDA does not intend...
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 law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process...
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 audit requirement for receiving facilities and importers, if other supplier verification methods are used instead. This...
WHY IS BEING A CRONS CROSS-BORDER WORKER A GREAT OPPORTUNITY?
Experience Report by Alix AUTER (KVALITO Life Science Consultant) “Wisdom is to have dreams big enough not to lose sight when we pursue them.” Oscar Wilde “Don’t settle down and sit in one place, move around, be...
