Medical Device Development Firm Glossary of terms and abbreviations.pdf

MEDICAL DEVICE AND DEVELOPMENT
TERMS AND ACRONYMS
PREPARED BY SPECK DESIGN 2022

21 CFR PART 11
Part 11 of Title 21 in the Code of Federal Regulations, it is mainly referred to as 21
CFR Part 11 or Part 11. It institutes the FDA acceptance criteria for electronic
records, electronic signatures, and handwritten signatures on electronic
documents. Applies to the medical device, pharmaceutical, biotechnology, and
other FDA-regulated industries.
21 CFR PART 820
Quality system regulations (QSR )maintained by the FDA that institute the quality
system requirements for all medical device manufacturers in the US.
Manufacturers must establish and maintain the appropriate quality system for the
medical device they produce to ensure safety and efficacy for its intended use
under 21 CFR Part 820.
483 OBSERVATION
An "inspectional observation" notice issued by an FDA inspector to flag possible
regulatory violations found during an inspection. A Form 483 observation is
published under the FDA jurisdiction. Failure to comply is escalated via a warning
letter.
510(K) PRE-MARKET NOTIFICATION
A regulatory pre-market submission for FDA Class I, II, or III medical devices that
don't otherwise require pre-market approval. This submission aims to demonstrate
a safe and effective device that is substantially equivalent to an already legally
marketed device.
APPLICATION LIFECYCLE MANAGEMENT (ALM)
The specification, design, development, and testing of software tools. ALM
systems are applied to manage quality and show compliance during the software
delivery process.

AUDITING ORGANIZATION (AO)
An organization responsible for auditing medical device manufacturers. They
evaluate adherence to quality management system requirements and other
medical device regulatory requirements. They can be an independent
organization or a Regulatory Authority (RA). When participating in the Medical
Device Single Audit Program (MDSAP), AOs may conduct a regulatory audit of a
manufacturer to satisfy the relevant requirements of RAs participating in MDSAP.
APPROVED SUPPLIER LIST (ASL)
An internal list maintained by medical device manufacturers to track vendors that
have been verified to meet the production company's quality and performance
standards.
BILL OF MATERIALS (BOM)
A comprehensive list of raw materials, assemblies, and subassemblies needed to
produce a medical device and the quantities required for each.
A BOM is required to carry out change management processes for a medical
device.
COMPETENT AUTHORITY (CA)
A body within the government of an EU Member State that translates the
requirements of Europe's medical device regulation (MDR) into the national law of
each Member State. The Federal Institute for Drugs and Medical Devices (BfArM),
for example, is the CA for Germany.
CONFORMITY ASSESSMENT (CA)
An assessment to determine that a medical device is safe and performs as
intended by the manufacturer done by an EU Notified Body. Medical devices are
required to pass a conformity assessment to obtain CE Marking.

COMPUTER-AIDED DESIGN (CAD)
The software that allows device manufacturers and designers to draft medical
device designs with measurements and specifications.
CORRECTIVE AND PREVENTIVE ACTION (CAPA)
A medical device organization's quality system process is the means by which it
reduces and/or eliminates possible sources of risk and regulatory non-
conformance or noncompliance.
CE MARKING (CE MARK)
The CE mark is a certification that medical device manufacturers must obtain
before their products may be sold in the European Union (EU) market.
EU CE Marking is a third-party certification that identifies medical device
compliance (where applicable) with the EU's Medical Device Regulations (MDR).
EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)
The European Union's public standards body that develops medical device
standards for sale in the EU. CEN is similar to the Food and Drug Administration
(FDA) in the US, a body that enforces medical device regulations.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
The U.S. Food and Drug Administration's (FDA) division that regulates the approval
of medical devices for sale in the United States market. The CDRH also monitors
the performance, manufacturing, and safety of approved medical devices.
CLINICAL EVALUATION REPORT (CER)
A report that provides clinical evidence a medical device will perform as expected,
ensuring no safety issues occur while using it. EU regulations require medical
device manufacturers must undertake a conformity assessment, including CER
certification, to legally market their items in the European Union.

COST OF QUALITY (COQ)
A method of quantifying the financial impact that a quality system and its
procedures have on an organization. CoQ may be used by medical device
businesses to calculate potential savings and compare them to the costs of
internal process improvement.
COMPUTER SYSTEM VALIDATION (CSV)
Refers to a procedure used to show that medical device manufacturing computer
systems, including hardware and software, comply with the regulations outlined in
21 CFR Part 11.
CURRENT GOOD MANUFACTURING PRACTICES (CGMP)
The FDA's minimum requirements for manufacturing processes and facilities. The
FDA's cGMP standards provide a framework for medical device manufacturers to
follow, allowing them greater flexibility in meeting various requirements for quality.
DOCUMENT CHANGE ORDER (DCO)
A formalized change-management procedure for medical devices. The DCO
process involves making requests for changes to a document or system in a
standardized, trackable manner inside an organization.
DE NOVO
A regulatory pathway classification process implementing a risk-based
methodology for new medical devices to be granted market entry for US sales.
General controls must demonstrate that the device is safe and effective for its
declared purpose in order for a De Novo submission to be approved by FDA.

DEMING CYCLE
A methodology used to monitor quality efficacy that serves as a foundation for
traditional quality assurance. The Deming Cycle model is comprised of four parts:
plan, do, study, and act, often summarized as PDSA.
DESIGN CONTROLS (DC)
A systematic process defined by the FDA in 21 CFR 820.30 to ensure specific
design requirements are met by documented procedures during the design of a
medical device. DCs are used to demonstrate that a medical device is safe and
effective and performs to expectation. A robust design control system will readily
prove your device meets the needs and requirements of its users.
DESIGN DOSSIER (DD)
All the contents of a technical file (TF) used to describe a medical device's design,
manufacturing, and performance. A DD will also include documentation that
demonstrates conformity to regulatory requirements applicable to the medical
device.
DESIGN OF EXPERIMENT (DOE)
A methodology for medical device manufacturers and engineers to validate
internal processes, predict process variability, improve and maintain product
quality.
DESIGN FOR MANUFACTURE (DFM)
A process for optimizing the design of a medical device specifically for
manufacturing. The DFM approach considers both the production and
manufacturing cost as well as regulatory compliance and product performance.

DESIGN HISTORY FILE (DHF)
A file with all documentation regarding the design and development of a medical
device: under FDA 21 CFR Part 820, medical device manufacturers in the
U.S.market must maintain a DHF.
DEVICE HISTORY RECORD (DHR)
A record of production for a medical device that demonstrates it was
manufactured according to the device master record (DMR). In the U.S., medical
device manufacturers must maintain a DHR under CFR Part 820.184. It contains
information like acceptance records for batches of products, unique product
identifiers, and product counts.
DEVICE MASTER RECORD (DMR)
A record of the information and specifications needed to produce a medical
device. The DMR has instructions for manufacturing, drawings, and specifications
of the medical devices. It also contains the requirements for labeling and
packaging. The FDA requires manufacturers to maintain a DMR under CFR Part
820.181.
DOCUMENT MANAGEMENT SYSTEM (DMS)
A management tool used to store and manage documents related to the
development of a medical device. It can be used to track changes made to
documents throughout the product lifecycle. A DMS is not the same as a Quality
Management System for storing documents but is also used for focus on
regulatory compliance.
ENGINEERING CHANGE ORDER (ECO)
The process triggered when there is an issue with a medical device's performance,
cost-effectiveness, or manufacturing process. An ECO is usually followed by an
analysis to decide if action should be taken. Depending on the type of change, an
ECO has the potential to lead to a CAPA investigation.

ESTABLISHMENT INSPECTION REPORT (EIR)
A report made by FDA when Form 483 is issued after an inspection. The next steps
after being issued an EIR from FDA will be determined by the nature and
seriousness of the issues reported along with the 483 response. The FDA may
decide to issue a warning letter if the deficiencies are severe enough.
ENTERPRISE RESOURCE PLANNING (ERP)
The management of internal business processes of a medical device organization.
It is often carried out using ERP tools to collate and organize business data,
automate HR processes and other business practices.
IN-VITRO DIAGNOSTIC REGULATION (IVDR)
Europe's newest regulation IVDR 2017/746 for in-vitro diagnostic devices. This
regulation will be effective on 26 May 2022. The IVDR requires current IVD devices
in the EU marketplace to recertify compliance with the new in-vitro diagnostic
devices (IVDD) directives.
EU MEDICAL DEVICE DIRECTIVE (MDD)
The Directive for medical devices sold in the European marketplace (replaced in
2017by the MDR). The aim of which was to bring together laws and standards
covering medical devices sold in the European Union.
EU MEDICAL DEVICE REGULATION (EU MDR)
A common abbreviation for the medical device Regulation (EU) 2017/745. This
mandate regulates the quality and safety requirements for EU medical devices.
The EU MDR supersedes the former medical device directives (MDD) up until
2017. It emphasizes the total product lifecycle approach.

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)
(GSPRs) of the new EU MDR that medical device manufacturers are required to
comply with. The regulation splits GSPRs into three chapters: general
requirements, design and manufacturing requirements, and information supplied
with the device requirements.
HAZARD IDENTIFICATION (HID)
A risk management process device manufacturers use to decide whether
situations, processes, or items associated with the production of their medical
device could potentially cause harm.
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
An FDA exemption that lets investigational devices to be used for testing a medical
device for pre-market approval standards. An IDE may be used to accumulate data
on the safety and effectiveness of the medical device to be submitted for review by
the FDA.
IEC 60601
A standard related to electrical medical equipment. All medical devices containing
electronics must meet the IEC 60601 requirements. An integral aspect covered in
IEC 60601 is Programmable Electrical Medical Systems. PEMS consists of
software, firmware, and equipment that can be programmed to carry out functions
in medical care or treatment. The standard also applies to mechanical safety,
labeling, and risk management.
IEC 62304
A framework for software that outlines engineering and documentation best
practices. It is FDA recognized and provides a risk-based framework used
throughout the entire medical device software lifecycle.

INSTRUCTIONS FOR USE (IFU)
Instructional materials used to communicate information relevant to the end-user.
These materials need to take into account the capabilities and limitations of the
end-user so as to communicate instructions clearly and objectively.
INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)
A voluntary group of international medical device experts who work to standardize
medical device standards and regulations. The Global Harmonization Task Force
is superseded by The IMDRF.
INSTALLATION QUALIFICATION (IQ), OPERATIONAL QUALIFICATION (OQ),
AND PERFORMANCE QUALIFICATION (PQ)
Installation Qualification, Operational Qualification, and Performance Qualification
All terms related to medical device software and equipment validation. IQ pertains
to the correct installment of software or equipment. OQ concerns meeting the
mandated regulatory requirements. PQ assures compliance of the software or
equipment performance.
INSTITUTIONAL REVIEW BOARD (IRB)
A body that oversees medical research on humans in the U.S. It ensures that the
human rights of all medical research subjects are protected. An IRB has the power
to approve or disapprove research and also to request modifications to research
practices.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
A non-governmental organization of experts that provides voluntary international
standards based on the proficiency of subject matter experts who are members.
The purpose of which is to enable and encourage innovative solutions to
worldwide challenges.

ISO 13485:2016
An internationally synthesized standard for medical device quality management
systems (QMS). QMS contents need to address the specific, applicable
requirements outlined in this standard to align with ISO 13485:2016 as well as the
applicable regulatory requirements in alignment to where the medical device will
be manufactured and marketed.
ISO 14971:2019
The latest version of the international measure for medical device risk
management. This standard is globally recognized and offers best practices for
implementing a proactive approach to risk management throughout the full
lifecycle of a medical device.
ISO 9001
An international standard that outlines the requirements for quality management
systems. It falls under the umbrella of the ISO 9000 standard. ISO 9001 is the only
standard that gives a certification pathway for manufacturers. It assumes a
specialized focus on making sure users receive good-quality products and
services.
IN VITRO DIAGNOSTIC (IVD) DEVICES
References In Vitro Diagnostic devices. IVD, as defined in IVDR (EU) 2017/746,
describes devices or equipment intended to be used in vitro for the examination of
specimens, including blood and tissue donations originating from the human
body.
MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE)
A database for electronic medical device reporting (eMDR). Data is submitted to
the FDA by various parties: manufacturers, importers, device user facilities, health
care professionals, patients, and consumers.

MEDICAL DEVICE REPORTING (MDR)
A data reporting tool maintained by FDA. It monitors the performance and safety of
medical devices after they enter the market. MDR is a voluntary reporting tool and
can be used by both medical device manufacturers and consumers for public use.
MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)
A program for medical device manufacturers that allows them to gain access to
multiple global markets through a single audit. The five current participating
regions of MDSAP are Australia, Brazil, Canada, Japan, and the United States.
MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA)
Changes to the fee structure medical device companies are expected to pay to
FDA to register their establishments and medical devices. Also applies to
applications or notification submissions made to the FDA.
MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM (MDQMS)
A ground-up quality management system for the medical device industry. It differs
from legacy QMS and typically includes templates and workflows that are in line
with the medical device industry requirements and best practices.
MANUFACTURING RESOURCE PLANNING (MRP)
A method of compiling, organizing, and planning numerous activities carried out
by a medical device manufacturer. This methodology simulates hypothetical
scenarios to ensure resources are being effectively implemented. It may also be
referred to as ERP.
NOTIFIED BODY (NB)
A third-party auditing organization responsible for assessing the quality and
conformity of medical devices looking to enter the EU market.

NONCONFORMANCE REPORT (NCR)
A report used to document non-conforming material discovered during quality
control activities or medical device inspection. It both identifies and details issues
of non-conformance, the level of impact of non-conformance, how it occurred, and
how it will be managed to avoid recurrence.
NONSIGNIFICANT RISK (NSR)
A measure of risk outlined by ISO 14971. A risk can be significant or nonsignificant.
Determining the risk category involves assessing the likelihood of direct harm, the
probability of harm from not using the medical device, and the probability of harm
from misinformation.
OWN BRAND LABELING (OBL)
When a manufacturer sells and markets a medical device in the EU with an existing
CE Marking and therefore under its own brand.
ORIGINAL EQUIPMENT MANUFACTURER (OEM)
A company that produces goods used as subparts in products of a third-party
company then sells the end products to consumers.
PERSONS RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
A European Commission requirement that manufacturers designate at least one
person with the necessary expertise in the discipline of medical devices within
their company as the Person Responsible for Regulatory Compliance (PRRC).
PRODUCT DEVELOPMENT (PD)
The process of building a medical device pre-market. The process includes all the
design and development of any product, including medical devices.

PRODUCT DATA MANAGEMENT (PDM)
The method of handling data related to medical devices within a software system.
PDM tools are used by medical device organizations to gather product data and
automate management protocols.
PRODUCT LIFECYCLE MANAGEMENT (PLM)
A system for management and oversight of the development and distribution of a
medical product. The process includes design, inception, marketing, regulatory
approval, manufacturing, and the post-market phases of a medical device until it
drops off the market.
PRE-MARKET APPROVAL (PMA)
A regulatory pathway to get a medical device to market that is required for Class III
devices by FDA regulations. The submission process for PMA usually involves
human clinical trials and laboratory testing to demonstrate the safety and efficacy
of the device.
POST-MARKET SURVEILLANCE (PMS)
The process of monitoring a medical device after it is released into the market for
sale, distribution, and use by patients. The PMS process involves gathering data
and feedback on the device's performance within the market. It is a required
process for compliance with several regulations, including 21 CFR Part 820, EU
MDR, and ISO 13485:2016.
PROOF OF PRINCIPLE (POP)
The demonstration that shows the initial concept behind a medical device is
achievable. A POP usually includes success criteria that must be met to proceed
with product development.

PRODUCTION PLANNING AND CONTROL (PPC)
A process used to organize medical device production, design, and development
activities, and manufacturing. A PPC process as a whole typically is made up of
inputs, outputs, and control systems. The Regulations for this type of design and
development planning are in FDA CFR 21 Part 820.30.
QUALITY ASSURANCE (QA)
A method used to prevent defective medical products. QA professionals work to
improve medical product development and testing processes. They also maintain
regulatory compliant marketing and distribution processes. A quality management
system is a QA tool in and of itself and is used as a single trusted reference for all
quality policies and procedures for the medical product.
QUALITY CONTROL (QC)
A system that focuses on identifying defects in a medical device's post-production
and prior to medical product distribution. Quality control is used to ensure medical
products conform to requirements and performance criteria at the point of the
end-user interaction. QC is a complementary aspect of a QMS.
QUALITY MANAGEMENT SYSTEM (QMS)
An organizational tool used to implement and maintain activities, documents, and
tasks as they relate to responsibilities, processes, procedures, and resources. A
QMS is critical to regulatory compliance and the production of safe and efficacious
medical devices. A basic quality system includes design controls, risk
management, document control, records management, and supplier
management.

QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)
An FDA inspection, also known as the QSIT method, that uses a top-down
approach to review the four subsystems within an organization's QMS. It involves
the FDA inspector starting by reviewing a company's procedures before getting
deeper into the quality records.
QUALITY SYSTEM RECORD (QSR)
A record used as a source file for all documentation, procedures, and records in a
QMS. Medical device companies can use QSR as a reference to guide other
aspects of their QMS. QSR may also refer to Quality System Regulation.
QUALITY SYSTEM REGULATION (QSR)
Requirements based on methods for facilities and controls used to carry out all
phases of medical device lifecycle processes. It includes designing,
manufacturing, storing, labeling, packaging, installing, and servicing of medical
devices intended for human use.
REGULATORY AFFAIRS (RA)
A professional in the medical device industry installed in a strategic role
throughout a medical device product lifecycle. It could be the formulation of a
market entry strategy for satisfying legal hurdles, regulatory submission protocol,
and/or post-market surveillance methods. The RA's role is essential for
communicating and executing appropriate strategies for medical regulatory
compliance.

RISK ANALYSIS (RA)
A method used in risk management to flush out risks associated with a design,
procedure, or process used in the manufacturing of a medical device. The process
encompasses identifying the medical device, the scope of the risk analysis, the
relevant dates, and the persons involved. Methods used to carry out risk analysis
for a medical device include preliminary hazard analysis, FMEA, and fault tree
analysis.
RISK MANAGEMENT (RM)
A process used by medical device companies to identify, control, and prevent
risks, hazards, and sources of harm that could come about during the use of a
medical device. ISO 14971:2019 is the internationally recognized standard for
medical device RM processes.
RESEARCH USE ONLY (RUO)
A term used to show that a medical device, instrument, or product does not have
an intended medical purpose; rather is being used for research purposes only.
SOFTWARE AS A MEDICAL DEVICE (SAMD)
A class of software for use in medical functions that do not need a hardware
component to perform that function. Software used to diagnose, prevent, cure, or
mitigate disease are all considered classes of SaMD.
SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)
A formal notice sent by a medical device organization to a supplier because of an
observance of non-conforming products or materials. The purpose of the SCAR is
to get action from the supplier and to correct the issue.

SUBSTANTIAL EQUIVALENCE (SE)
A regulatory requirement by FDA for clearing new medical products for market
through a 510(k) pre-market submission. To do so, a company must demonstrate
its device is as safe and effective as an established one. SE is a requirement for
regulatory submissions when a pre-market approval is not required.
SAFE MEDICAL DEVICES ACT (SMDA)
A 1990 law establishing HHS as the governing authority over medical device user
facilities for the reporting of medical devices that may have caused serious illness,
injury, or death.
STANDARD OPERATING PROCEDURE (SOP)
An internal procedure by which organizations standardize a routine process for
easy repetition. An SOP is usually a written document made up of instructions to
be followed. As part of their QMS, medical device companies are required to create
and maintain SOPs for all routine processes.
STATISTICAL PROCESS CONTROL (SPC)
A method used to control a process by utilizing statistical techniques. It entails
compiling data from a process and building a cause and effect model to predict
potential outcomes.
SIGNIFICANT RISK (SR)
A measure of risk as defined by ISO 14971. Under this regulation, any device that
could pose a serious risk to the health and/or safety of a human subject must be
categorized as SR.
SINGLE-USE DEVICES (SUDS)
Thee are disposable devices for the purpose of being used for one patient in a
singular event or procedure. These devices are created to be disposed of after use
and cannot be sanitized or re-used.

SUMMARY TECHNICAL DOCUMENTATION (STED)
The format manufacturers use to log information on how a medical device was
designed, developed, and manufactured for submission to an RA or Notified Body.
Technical Files require the STED format.
TECHNICAL FILE (TF)
The file or dossier for Class III medical devices. It encompasses specific details
about a medical device's design, function, composition, intended use, and a
clinical evaluation. To obtain a CE marking for a device, the TF is needed.
UNIQUE DEVICE IDENTIFICATION (UDI)
A system established by the FDA for cataloging and identifying all medical devices
for sale in the U.S. market. This system assigns each medical device a custom
identifier that can be read by both humans and machines. A UDI is different from a
UPC because it can only be used to identify a medical device on the FDA website
via the AccessGUDID portal.
UNIVERSAL PRODUCT CODE (UPC)
A barcode and 12-digit number printed on retail packaging. The code is used by
retailers to track inventory on all products, but for medical devices, it is considered
to be an alternative tracking method to the official identification system used by
FDA, the UDI.
VERIFICATION AND VALIDATION (V&V)
Activities for testing and confirming whether a medical device meets the design
criteria and procedures and is ready to be released for manufacturing. Design
verification ensures a medical device has been designed correction and validated.
The procedures involve careful tests, trials, and analyses.

VOLUNTARY ACTION INDICATED (VAI)
A term used by the FDA in the EIR to highlight regulatory action is not required
following notice of objectionable conditions or practices during an inspection. OAI
s the opposite of this and would indicate regulatory or administrative action is
required by FDA to correct an issue.
WARNING LETTER (WL)
An official notice made by FDA in response to regulatory violations. Often these
violations have been escalated from a 483 observation. Examples of violations
include wrongful claims about the device or missing design controls. A WL will
give a detailed explanation of the violation and corrective action plan
requirements for the medical device company.
WORK IN PROGRESS (WIP)
A term used to refer to a partially finished medical device in the manufacturing
process or within a design history record (DHR). Once inventory enters the
manufacturing process, it can no longer be classed as raw materials but is also not
a finished product, so it is classed as WIP.
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