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An A -Z of medical device development; acronyms, regulatory & technical terms

Medical Device Development Glossary-2The regulations and literature surrounding medical device development are packed with acronyms and technical terms assuming a shared understanding of key industry requirements and processes.

With so many governmental, certification and regulatory bodies overseeing the safe design, production and marketing of these products around the world, the use of abbreviations and technical terms can proliferate. These often overlap with each other and can describe different as well as similar or even identical processes and concepts.

Because of this, as you read around the subject and have discussions with professionals from various organisations it can be hard to keep track of the meaning and relevance of all the terminology and acronyms currently in use.

Beyond the med tech acronyms - what do they all mean?

So, with this in mind - here is an A- Z of some of the most common and more obscure technical terms and abbreviations (together with their definitions) that med-tech device developers can encounter in the literature and their dealings with regulators and collaborators across the globe.

A Glossary of terms for Medical Device Developers

BOM – Bill Of Material

List of raw materials, components and subassemblies that make a product.

CA - Competent Authority

Each member state in the European Economic Area has appointed a competent authority to perform certain functions required by Directive (2001/20/EC). The MHRA is the UK’s licensing authority and is the competent authority in the UK.

CA - Conformity Assessment

In the EU conformity with required regulatory standards can be self-assessed or carried out by a Notified Body, depending on the classification of the device in question. Conformity Assessment must be successfully carried out before a CE marking can be awarded and a product sold in the EU.

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 - European Conformity Marking

A CE marking (abbreviated from the French - ‘Conformité Européene’) is a certification mark that indicates conformity with medical device standards for products sold within the European Economic Area. You cannot legally sell a device in the EU without this marking.

Design dossier

A term used in the European MDD (Medical Device Directive) but which does not appear in the new EU MDR (Medical Device Regulation) which comes into force in 2020. It should be noted that the term ‘design dossier’ has now been replaced by the term ‘technical documentation’ in the EU MDR.

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.

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.

DoE – Design of Experiment

A systematic method to determine the relationship between factors affecting a process and the output of the process (cause and effect relationship).

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.

EDS – Engineering Design Specification

A document detailing the requirements that must be met in order for the product to meet the User Requirement Specification

EU IVDR - In Vitro Device Regulation

The EU Medical Device Regulation 2017/746 which governs the development of all In Vitro medical devices for sale in the European Economic Area.  The EU IVDR comes into force in 2022.

EU MDR - Medical Device Regulation

The EU Medical Device Regulation 2017/745 governs the development of general medical devices for sale in the European Economic Area. The EU MDR comes into force in 2020.

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 and ‘wet signatures’ in a compliant way.

FDA 21 CFR 820.181

This is the FDA regulation which contains requirements for the contents and management of the Device Master Record

FEA – Finite Element Analysis

A computerised method for predicting how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects.

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).

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 prioritise 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 commercialising a product can be done without infringing valid intellectual property rights of others.

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.

ISO 13485: 2016

ISO 13485:2016 is the recognised Quality Management standard for medical device regulators around the world.

MDD - Medical Device Directive

The abbreviation for the EU Medical Device Directive which is now being superseded by the EU MDR and EU IVDR

MDF - Medical Device File

In ISO 13485, Medical Device Files are documents that include descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, as well as, servicing and installation records and their guidelines. A medical device file must be kept for every device in your portfolio.

NB - Notified Body

A notified body is an organisation designated by an EU country to assess the conformity of certain medical devices. Notified Bodies carry out conformity assessment procedures set out in the legislation when a third party is required to do so.

PCB – Printed Circuit Board

Collection of electronic components connected via conductive tracks on a non-conductive board.

PIL – Patient Information Leaflet /Packaging Insert Leaflet

Information provided by the manufacturer about doses, side effects and contraindications for a pharmaceutical product or a drug/device combination product.

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.

PoP - Proof of Principle

The realisation of a method or idea to demonstrate its feasibility.

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 analysing, evaluating, controlling and monitoring risk.

SOP – Standard Operating Procedure

A detailed written instruction to achieve uniformity of the performance of a specific function.

STED: Summary Technical Documentation

One of the best known proposals for structuring technical documentation comes from the IMDRF (International Medical Device Regulation Forum). Many authorities and notified bodies use the STED (Summary Technical Documentation) as a guide for this activity.

TD - Technical Documentation

The EU MDR and IVDR require ‘technical documentation’ (once referred to as the Design Dossier or Technical File) to be maintained and auditable for every device in your portfolio. 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.

TI – Task Instruction

Detailed written instructions to achieve uniformity of the performance of a task.

TPR – Test Protocol

Detailed written document that outlines the requirements, activities, resources, documentation and schedules to be completed in order to execute a test.

UET – User Event Tree

A bottom up, causal failure analysis in which an undesired state of a system caused by the user is analysed using Boolean logic to model risk.

URS - User Requirement Specification

A document specifying what the user requires the product to do.

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Tags: FDA 21 CFR Part 11, medical device development, FDA