The literature surrounding medical device development is packed with acronyms and technical terms assuming the medical device engineer shall communicate in the common language based on these technical terms and acronyms.
Here is a glossary of the these acronyms and terms that medical device engineers and developers shall be familiar with in order to communicate effectively in medical device industry.
URS – User Requirement Specification
A document specifying what the user requires the product to do.
DHF – Design History File
A design history file is a repository for all records that demonstrate how your medical device was developed in accordance with an approved design plan. ISO 13485 and the FDA require developers to maintain a DHF for each type of device in their portfolio.
DHR – Device History Record
A combination of records containing the entire production history of a finished medical device.
DMR – Device Master Record
A Device Master Record is a compilation of all the instructions, drawings, documented specifications, labelling and packaging requirements that must be used to produce your medical device. It is the definitive instruction manual for the safe and effective production of your device.
DFM – Design For Manufacture
The process of designing a product with ease of manufacturing in mind, often with an end goal of making a better product at a lower cost.
DP – Detail Part (drawing)
A drawing containing sufficient information to allow effective production of a part.
DQ – Design Qualification
Documented verification that the proposed design of the device is suitable for the intended purpose.
BOM – Bill Of Materials
List of raw materials, components and subassemblies that make a product.
CAPA – Corrective Action Preventive Action
CAPA requirements are the regulatory demands ensuring a developer has clearly documented procedures for correcting and preventing existing and future nonconformities in their products, processes and quality management systems.
CE marking
A CE marking is a certification mark that indicates conformity with medical device standards for products sold within the Europe. You cannot legally sell a device in the EU without this marking.
EDS – Engineering Design Specification
A document detailing the requirements that must be met in order for the product to meet the User Requirement Specification
FDA 21 CFR Part 11
Part 11 sets out how a company operating in the US can use electronic quality records and digital signatures in place of paper-based documentation in a compliant way.
ISO 13485: 2016
ISO 13485:2016 is the recognized Quality Management standard for medical device regulators around the world.
FEA – Finite Element Analysis
A computerized method for predicting how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects.
FMEA – Failure Mode Effects Analysis
FMEA is a structured approach to discovering potential failures that may exist within the design of a medical device product or process. It is a model used to prioritize potential defects of a medical device based on their severity, expected occurrence and likelihood of detection.
FTA – Fault Tree Analysis
A top down, deductive failure analysis in which an undesired state of a system is analysed using Boolean logic to combine a series of lower level events.
FTO – Freedom To Operate
Determining whether testing or commercializing a product can be done without infringing valid intellectual property rights of others.
GCP – Good Clinical Practice
GCP are the ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve human beings. This is vital for the medical device industry.
GDocP – Good Documentation Practice
These are the standards by which data and documents should be created and maintained in the healthcare industry.
GMP – Good Manufacturing Practice
GMP also referred to as cGMP (Current Good Manufacturing Practice) are regulatory requirements designed to ensure medical devices are consistently manufactured and controlled according to quality standards – thus reducing the risk of harm to consumers.
HID – Hazard Identification
Identification of potential conditions, events or circumstances that could lead to, or contribute to an unplanned or undesirable event.
IFU – Instructions For Use
Information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken.
IP – Intellectual Property
Intangible property that is the result of creativity, such as patents, copyrights, designs, inventions, etc.
510 (K)
A 510(K) is a premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective as another legally marketed device that is not subject to premarket approval (PMA).
PMA – Premarket approval
Premarket Approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
Post-market surveillance (PMS)
Post-market surveillance is a proactive and systematic process which manufacturers implement and carry out to take corrective and preventive action (CAPA) in accordance with information gathered about the performance of their medical devices.
PRS – Product Requirement Specification
Definition of requirements needed to be achieved in order for the product to meet the User Requirement Specification.
QC – Quality Control
Activities intended to ensure a manufactured product meets acceptance criteria.
QMS – Quality Management System
A QMS formally documents the processes, procedures, and responsibilities for achieving quality policies and objectives in the development and management of your medical device. A QMS can be a paper based or digital system.
RA – Risk Analysis
Systematic use of available information to identify hazards and eliminate risk.
RMP – Risk Management Plan
A documented plan for the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.
SOP – Standard Operating Procedure
A detailed written instruction to achieve uniformity of the performance of a specific function.
TD – Technical Documentation
The Medical Device Regulations (MDR) require ‘technical documentation’ to be maintained and auditable for every medical device. This technical documentation can be used to prove that a product has been designed according to the requirements of a quality management system and the relevant regulation.
Test Protocol
Detailed written document that outlines the requirements, activities, resources, documentation and schedules to be completed in order to execute a test.