SMART quality & compliance
What is and what is not a Software as Medical Device (SaMD)
The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the availability of certain mobile or web-based apps have helped medical personnel better handle their jobs and allowed patients to access medical information or seek a medical solution more independently. However, when a topic revolves around medical affairs, it always comes with stringent scrutiny, leaving many software developers and manufacturers confused as to when the software is defined as a Software as Medical Device (SaMD) and how this differs from a conventional medical device? Clear guidelines have been developed by the International Medical Device…
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SMART quality & compliance
Agile and Scrum in GxP Environments – How does it Work in Practice?
“Intelligence is the ability to adapt to change.” (Stephen Hawking) Introduction To date, classical methodologies, such as Waterfall or V-model, are standard practices. But Agile frameworks like Scrum are lately gaining more and more popularity. Several big companies started to work in an agile way, like IBM1, Microsoft2 or Spotify3. Agile software development can contribute to businesses being more efficient by supporting a faster implementation and validation, and thus enabling the development and delivery of cost-effective, safe, and compliant products with a decreased time to market4. Although a complete switch to an agile framework would be most effective, this is…
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SMART quality & compliance
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 satisfaction in the intended use environment. In parallel, usability engineering is defined as Human Factors Engineering. It is applying knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability. Usability have an impact on safety and performance of MD. Indeed with the right usability, some medical errors, injuries can be avoid. MDR : “Reduce, as far as possible, the risks related to the…
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SMART quality & compliance
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 protection in diagnostic X-ray equipment. The other standards are related to the specific characteristic of all medical electrical equipment not fully addressed in the standard 60601-1, as standard 60601-1-2 states for EMC and 60601-1-8 for Alarms. An electrical medical device needs to comply with the IEC 60601-1. Every point of the standard needs to be verified and referenced in a Compliance or Conformity Matrix. Tests must be conducted on the device…
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SMART quality & compliance
Precision Medicine
Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel therapeutics that integrate genomics and big data (genetic, clinical, molecular, diagnostic and environmental data) to detect pathogenic events at the genome level. Biologics, vaccines and highly selective NCEs are matched with disease targets validated by human genetics, to tailor medicines to patients. A human has 99.9% genetic similarity to the next human, 96% genetic similarity to a chimpanzee, 90% genetic similarity to a cat, and 60% genetic similarity to a chicken, and a banana. Fruit fly protein sequences have mammalian homologs while almost 75%…
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SMART quality & compliance
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary. A Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Validation: Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled. Qualification: Process to demonstrate the ability to fulfill specified requirements In general : Validation: For systems or general topics: process, systems, etc. Qualification: For single or individual items within your system, process: Equipment, lab methods, etc Below is a simplified process diagram on how to validate a system…
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SMART quality & compliance
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 probability of occurrence(O). A numerical score is assigned to assess the risk. Risk = probability of damage x severity of damage. A simple evaluation scale needs to be used and it must be equivalent for all products. See the table below as an example: Then the score is interpreted by this table: Then risk control measures must be defined…
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SMART quality & compliance
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 product. The International Electrotechnical Commission (IEC) is an international standards organization that prepares and publishes international standards and technical specifications for all electronic, electrical, and associated technologies – collectively known as “electrotechnology”. See: IEC 62304:2006. This regulation, [1] in section 4.3, defines software safety classes, based on severity (not probability) of risk: – Class A: No injury or damage to health is possible – Class…
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SMART quality & compliance
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 standard by which to respect the regulations of both markets. A SOUP is a “software item that is already developed and generally available, and that has not been developed for the purpose of being incorporated into the medical device (also known as “off-the-shelf software”) or a software item previously developed for which adequate records of the development process are not available.” (Source: IEC 62304). The FDA defines SOUP as some…
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SMART quality & compliance
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 did a poor job no matter what you really did.” —Marco Polisena Introduction Good Documentation Practices (GDP) has evolved to be one of the essential Good Practices in regulated environments such as pharmaceuticals manufacturing for many years now. Having developed from predicate rules for record-keeping in quality system management, as well as 21CFR 11 for electronic records and electronic signatures, GDP has evolved to become a quintessential tool for documents industry. “In any regulated industry, documentation can provide…
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