Software as a Medical Device Flashcards
What are the 2 types of software?
- Computer programmes
- Functional documents
What is a computer program?
A syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task, or problem.
What types of computer programme are there?
- Uncompiled software, if all the installation instructions are provided
- Freeware/open-source
What is the international standards organisation?
A global network of the world’s leading standardisers. They develop and publish international standards and complete standards-related research.
What is the international electrotechnical commission?
An international organisation focuses on electrical, electronic, and related technologies. It provides a global, neutral, independent standardisation platform and publishes thousands of international standards.
What is a functional document?
Software that requires separate software to perform its function. Often this will be a general purpose application.
Give 4 examples of functional documents
- PDF with logical links
- Spreadsheets with calculations
- Documents with macros
- Interactive web pages
What is the Medicines and Healthcare products Regulatory Agency?
An agency of the Department of Health and Social Care. It is the UK’s ‘competent authority’ that monitors and ensures compliance of medical devices with regulations, consults on and develops regulations, and manages the public access register of medical devices on the UK market.
How does the MHRA monitor and ensure compliance of medical devices with regulations?
- Publishing alerts, recalls, and safety information
- Requesting market withdrawal
- Prosecuting where necessary
- Evaluating medical devices being trialled
What is the US equivalent of the MHRA?
The Food and Drug Administration (FDA)
What are the intended uses of medical devices?
- Diagnosis, prevention, monitoring, treatment, and/or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
- Investigation, replacement, or modification of the anatomy or of a physiological process
- Control of contraception
What type of clinical products are not qualified as medical devices?
- Products used solely for research
- Products manufactured in-house
What information determines the medical purpose of a device?
- What the manufacturer states in the device’s labelling
- Instructions for use
- Any promotional materials
What 4 things does the intended purpose of a device describe?
- The structure and function of the software
- The intended population
- The user
- The use environment
What is the intended use of in vitro diagnostic medical devices (IVD MDs)?
They are intended for the examination of specimens, including blood and tissue donations, derived from the human body solely or principally to provide infomation:
- concerning a physiological or pathological state
- concerning congenital abnormality
- to determine the safety and compatability with potential recipients
- to monitor therapeutic measures
Does stating that something is ‘not a medical device’ stop it from being one?
Not if medical claims about the device are being made or implied
What documents can be used to determine what is a medical device?
Regulations: Medical Device Regulations 2002
Standards and guidance: from BSI, IEC, MDCG, MHRA, and ISO
How can you tell if a medical device conforms with the Medical Device Regulations?
It will bear the UKCA mark (or the CE mark in some cases)
How is the conformity of a medical device with the medical device regulations assessed?
Low-risk devices can self-certify their conformity by issuing a ‘declaration of conformity’.
Higher-risk devices are assessed by a notified body that produces a certificate.
What is the British standards institution?
The UK’s national standards body. This is a non-profit company, is one of several ‘notified bodies’, and is one of many certifiers of quality management systems.
What are the main components of a UKCA marking?
What is in-house software?
Software not placed on the market or transferred to another legal entity.
Is software a medical device?
Yes, unless it is used solely for research or manufactured in-house.
Software that meets the definition of a medical device is required to be ____ marked in line with the UK Medical Device Regulations 2002.
UKCA
