Glossary

any wrapping, containers, etc., used to protect, to preserve the sterility of, or to group medical devices.

[FDA guidance: Deciding When to Submit...(2014)]

the grant of a property right to the inventor of an invention

[USPTO]

living being (person) undergoing a medical, surgical or dental procedure

Note: A patient can be a user.

[IEC 62366-1:2015]

Patient-specific devices are, in general, ones in which ranges of different specifications have been approved or cleared to treat patient populations that can be studied clinically. Premarket submissions for such devices are sometimes referred to as “envelope” submissions because their approval or clearance covers the entire range of specifications data they contain to support. The final manufacturing of these devices can be delayed until physicians provide imaging data or other information to the manufacturer to finalize device specifications within cleared or approved ranges. As a result, such devices are specifically tailored to patients. For example, a manufacturer of an ankle replacement device could submit a 510(k) to cover a range of specifications for different system components to accommodate multiple patients with different anatomical characteristics.

Note: While some in industry have sometimes colloquially referred to these devices as “customized,” they are not custom devices meeting the FD&C Act custom device exemption requirements unless they comply with all of the criteria of section 520(b). Marketing applications are required for these device types because the devices and patient populations can be defined and studied.

[FDA guidance: Custom Device Exemption (2014)]

a formal (documented) or informal review focused on a specific aspect (topic) of product development

Note: Peer reviews are typically narrower in scope than design reviews and are considered verification activities that precede and/or facilitate the successful completion of design reviews. Other names for peer reviews include: functional review, cross-functional review, technical review, topic review, etc.

assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use

[ISO 13485:2016]

an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device

[EU IVDR 2017/746]

study undertaken to establish or confirm the analytical or clinical performance of a device

[EU IVDR 2017/746]

a documented review of product development life-cycle phase activities to confirm process function alignment, completion of required tasks/deliverables, and leadership buy-in to complete the phase

the first making available of a device, other than an investigational device, on the Union market

[EU MDR 2017/745]

the first making available of a device, other than a device for performance study, on the Union market

[EU IVDR 2017/746]

after placement on the market

[ISO 13485:2016]

systematic process to collect and analyze experience gained from medical devices that have been placed on the market

[ISO 13485:2016]

all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions

[EU MDR 2017/745, EU IVDR 2017/746]

part of the life-cycle of the medical device after the design has been completed and the medical device has been manufactured

Examples: Transportation, storage, installation, product use, maintenance, repair, product changes, decommissioning and disposal.

[ISO 14971:2019]

the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device

[FDA 21CFR822]

before placement on the market

a device commercially distributed in the United States prior to May 28, 1976 that has not been significantly changed or modified since then, and for which premarket approval has not been required under section 515(b) of the FD&C Act

[FDA guidance: Deciding When to Submit...(2014)]

• Precautions describe any special care to be exercised by a practitioner or patient for the safe and effective use of a device. This definition also includes limitations stated for IVDs.


• Warnings describe serious adverse reactions and potential safety hazards that can occur in the proper use or misuse of a device, along with consequent limitations in use and mitigating steps to take if they occur.


• Contraindications describe situations in which the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.

[FDA guidance: Deciding When to Submit...(2014)]

a legally marketed device (as defined in 21 CFR 807.92(a)(3)) to which a new device may be compared for a determination regarding substantial equivalence because the devices have the same intended use and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness

[FDA guidance: The 510(k) Program...(2014)]

any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. “PMA” includes a new drug application for a device under section 520(1) of the act.

[FDA 21CFR814]

action to eliminate the cause of a potential nonconformity or other potential undesirable situation

[ISO 9000:2015]

specified way to carry out an activity or a process

[ISO 9000:2015, ISO 14971:2019]

set of interrelated or interacting activities that use inputs to deliver an intended result

Note 1: Whether the “intended result” of a process is called output, product or service depends on the context of the reference.
Note 2: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.
Note 3: Two or more interrelated and interacting processes in series can also be referred to as a process.
Note 4: Processes in an organization are generally planned and carried out under controlled conditions to add value.
Note 5: A process where the conformity of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.

[ISO 9000:2015, ISO 14971:2019]

establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications

[FDA 21CFR820]

Cleaning, disinfection, or sterilization of an unused medical device

components, manufacturing materials, in-process devices, finished devices, and returned devices

[FDA 21CFR820]

result of a process

Note 1: There are four generic product categories, as follows:
- services (e.g. transport);
- software (e.g. computer programs, dictionary);
- hardware (e.g. engine mechanical part);
- processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product "automobile" consists of hardware (e.g. tyres), processed materials (e.g. fuel, colling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman).
Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and the customer and is generally intangible. Provision of a service can involve, for example, the following:
- An activity performed on a customer-supplied tangible prodict (e.g. automobile to be repaired);
- an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
- the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
- the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.
Note 3: This definition of "product" differs from the definition given in ISO 9000:2015.

[ISO 13485:2016]

a submission as set forth in section 515(f) of the Federal Food, Drug, and Cosmetic Act

[FDA 21CFR4]

failure of the medical device or medical device accessory (including labeling and packaging) to perform or function as intended including any deviations from the device's performance specifications

group or subgroup of product characterized by similar attributes determined to be equivalent for evaluation and processing purposes

[ISO 11139:2018]

a firm's removal or correction of a marketed product

Note: PFA includes recalls and market withdrawals, but not stock recoveries.

measures that ensure that the produced product (at the manufacturer’s location) conforms to product design specifications with identification and traceability maintained throughout production

process of combining various inputs in order to produce a packaged medical device that is suitable for delivery

the financial benefit realized when revenue generated from a business activity exceeds the expenses, costs, and taxes involved in sustaining the activity in question

Note: Profit is calculated as total revenue less total expenses.  Any profits earned funnel back to business owners, who choose to either pocket the cash or reinvest it back into the business.

[Investopedia]

a financial statement that summarizes the revenues, costs, and expenses incurred during a specified period, usually a fiscal quarter or year

Note: The P&L statement provides information about a company's ability or inability to generate profit by increasing revenue, reducing costs, or both. The P&L statement is also known as the statement of profit and loss, income statement, statement of operations, statement of financial results or income, earnings statement, or expense statement.

[Investopedia]

unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources

Note 1: An individual project can form part of a larger project structure and generally has a defined start and finish date.
Note 2: In some projects the objectives and scope are updated and the product or service characteristics defined progressively as the project proceeds.
Note 3: The output of a project can be one or several units of product or service.
Note 4: The project’s organization is normally temporary and established for the lifetime of the project.
Note 5: The complexity of the interactions among project activities is not necessarily related to the project size.

[ISO 9000:2015]

 

planning, organizing, monitoring, controlling and reporting of all aspects of a project, and the motivation of all those involved in it to achieve the project objectives

[ISO 9000:2015]

personnel with direct responsibility for the completion of product development project tasks and/or deliverables

meeting to discuss project progress, key project decisions, and resolve any action items (open issues)

the subjects are identified at the beginning of the surveillance and data or other information will be collected from that time forward (as opposed to retrospective surveillance)

[FDA 21CFR822]

product provided by a party outside the organization's quality management system

Note: The provision of product does not necessarily infer a commercial or financial arrangement

[ISO 13485:2016]

measures that ensure that all purchased or otherwise received products and services conform to specified purchasing requirements

the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose

[EU MDR 2017/745]

the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose

[EU IVDR 2017/746]