Software as a Medical Device Overview

A collection of vocabulary flashcards based on key terms and concepts from the lecture notes about Software as a Medical Device.

What is Software as a Medical Device (SaMD)?

Any software intended to be used for medical purposes without being part of a hardware medical device.

What does UKCA marking indicate?

A certification mark that indicates conformity with the relevant UK legislation for products sold in Great Britain.

What are the Medical Device Regulations (UK MDR 2002)?

The regulations that govern the safety and performance of medical devices in the UK, ensuring they meet necessary standards.

What is the role of the Medicines and Healthcare Products Regulatory Agency (MHRA)?

The UK's regulatory body responsible for ensuring medicines and medical devices are safe and effective.

What does the International Electrotechnical Commission (IEC) do?

An organization that prepares and publishes international standards for electrical, electronic, and related technologies.

What is Critical Awareness?

An understanding and ability to challenge assumptions, contextualize information, explore alternatives, and ask reflective questions.

What is a Functional Document?

Software that requires separate software to perform its function, such as spreadsheets or interactive web pages.

What are In Vitro Diagnostics (IVD MDs)?

Medical devices used for examination of specimens derived from the human body, aimed at providing medical information.

What is Post-Market Surveillance (PMS)?

The activity of monitoring the safety and effectiveness of a medical device after it has been placed on the market.

What is Risk Management in the context of medical devices?

The systematic process to identify, evaluate, and mitigate risks associated with medical devices.

What is Clinical Evaluation?

A systematic process to assess the clinical safety and performance of a medical device based on clinical data.

What is Decision Support Software?

Software designed to assist healthcare professionals in making clinical decisions based on data analysis.

What are Harmonised Standards?

Standards that are recognized by regulators as providing a presumption of conformity with regulatory requirements.

What is ISO 13485?

An international standard for quality management systems specific to the medical devices industry.

What is an Algorithm?

A step-by-step procedure for calculations or problem-solving, often used in decision support tools.

What is Legislation in the context of medical devices?

A law or set of laws enacted by a governing body, such as regulations for medical devices.