Glossary of terms

510(k): The process required by the FDA to sell a medium-risk medical device (or IVD) in the U.S. It is also known as a Pre-market Notification.

21 CFR 820: It is the law established by the FDA for medical device manufacturers to have a correct QMS according to these documents. It governs the methods, facilities, and controls used for medical device design, manufacture, packaging, labeling, storage, installation, and service.

CAPA: Corrective and Preventative Actions. In the event of an audit finding or process failure, a CAPA will be opened to address the issue and put controls in place. CAPAs are classified based on risk and have to be documented on the CAPA Form and tracked in the CAPA Log to be reviewed in the Management Review Meeting.

CE Mark: The medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU).

cGDP: Current Good Documentation Practice. The practice through which all Quality Records need to be completed. Process includes recording data, document approval, document review, etc.

cGMP: Current Good Manufacturing Practice. Regulations developed and enforced by the FDA, designed to enhance consumer confidence by providing for systems to assure proper design of products and adequate monitoring and control of manufacturing processes and facilities.

Change Controls: Ways to track Documents Revisions and Changes. Only eﬀective documents may be used for completing or recording data.

DCO: A Document Change Order is a formalized process in medical device change management. The DCO process involves change requests to be made within an organization to a document or system in a standardized, traceable manner.

DHF/TF: The Design History File (DHF) and the Technical File (TF) are core regulatory documents for a medical device. Quality Engineers will help to create your device DHF and/or TF to ensure compliant design control, risk management, design transfer, and manufacturing oversight.

DHR: Device History Record. Records for each batch/lot/unit to demonstrate production according to DMR; includes dates of manufacture, quantity manufactured and released, acceptance records, ID, UDI, etc.

DMR: Device and process specifications, production, QA, QC, installation, maintenance, and servicing procedures.

Design Control: A formalized approach to the development of Class II and Class III medical devices. This process includes many layers of required documentation that show the FDA exactly how you have provided for the safety and eﬃcacy of your new device. Must be completed for any changes to the device or manufacturing process, including new suppliers or part of the device. All changes to the design must be validated prior to their release or implementation to ensure patient safety and eﬀectiveness of the device.

Design Validation: Established by objective evidence that device specifications conform with user needs and intended use(s).

Design Transfer: When the state of the device moves from Design to Manufacturing. However, you must continue to update Design History File (DHF) and Tech File (TF) even after Design Transfer occurs.

Document Control: A set of policies and procedures designed to ensure that there is organizational accountability for documents that are used to satisfy quality requirements at medical device companies.

Equipment Validation: Established by objective evidence that equipment consistently produce a result or product meeting predetermined specifications.

eQMS: An electronic quality management system or enterprise quality management system is software that documents and manages business processes for product development, quality, and compliance across an organization.

eStar: eStar is an interactive PDF form that guides applicants through the process of preparing a comprehensive 510k medical device submission to the FDA.

EU MDR: The European Union’s Medical Device Regulations- replaced the EU’s Medical Device Directive (MDD). Intended to ensure a high standard of quality and safety for medical devices being produced in or supplied into the European Single Market.

FDA-482: A FDA notice of inspection. The 482 explains the agency’s inspectional authority, and provides expectations for the inspector and the company.

FDA-483: A form used by FDA auditors to report inspection observations that could potentially lead to a compliance violation.

FMEAs: Failure Modes & Eﬀects Analysis. An important instrument to ensure product quality and safety, and to prevent errors.

Gap Analysis: A gap analysis identifies data gaps in existing procedures and product portfolios. A comparison of your procedures to the requirements in the FDA, ISO or MDR will help ensure that your processes generate devices compliant with current regulations.

GDP: Good Documentation Practice. Regulatory standards by which documents should be created and maintained.

Health Canada: Agency responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.

IFU: Instruction For Use. FDA-approved patient labeling for drugs that have complex or highly detailed patient-use instructions.

ISO 13485:2016: The most common medical device QMS regulatory standard in the world, focused on maintaining QMS eﬀectiveness and meeting regulatory and customer requirements. Because diﬀerent countries have diﬀerent standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets.

Identification: An important part of a post-market production process. One must be able to identify the status of all parts and materials of their product.

Internal Audits: All sections of the QMS must be internally audited at least once per year. Results must be documented in the Audit Report Form and reviewed at each Management Review Meeting. Any findings from the audits must be recorded by opening a CAPA. Employees cannot audit their own work, so Rook has been assisting clients with their internal audits for nearly a decade.

IVD: In Vitro Diagnostics- tests used on biological samples (such as tissues, blood or urine) to determine the status of a person’s health.

MDD: The European Medical Device Directive- replaced in 2021 by the EU Medical Device Regulation (EU MDR).

MDF: Medical Device File. Shows compliance to regulatory requirements: Device description and labeling, specifications, manufacturing through distribution procedures, measuring and monitoring.

MDR: Medical Device Report/Regulations. A MDR must be filed to the FDA or other Regulatory body in the event of a serious injury or death to a patient caused by a company’s product. This is diﬀerent and more severe than an Adverse Event, and the MDR Decision tree located in the procedure provides instruction on when to file an MDR or an Adverse Event. All employees must also be trained on how to receive complaint details and notify the Quality Manager in the event of a potential MDR.

Management Review: Must be conducted once per year for QMS, but quarterly review is recommended, particularly for startups. Management Review helps to outline goals and progress of the company, and is a great way to get management team on the same page.

NCR: Non-Conformance Report. The NCR form describes the actions required to document the NCR and must be traced on the NCR log. Prior to the release of the NCR, the material must be retested or reworked and the tests must be documented on the NCR Form which then must be approved by a trained operator.

Non-Conforming Materials: Any product or parts that are defective, counterfeit, or do not meet the requirements; these materials must be controlled and monitored. If material fails inspection or is deemed defective, a Nonconforming Report (NCR) form must be completed.

MDSAP: Medical Device Single Audit Program is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

PHAs: Preliminary Hazard Analysis

Process Validation: Established by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

QMS: Quality Management Systems ensure that medical device companies can eﬃciently produce eﬀective and reliable medical devices. Rook helps build the QMS so that our clients can get their devices to market faster than standard methods, and once on the market, use these systems to continue producing high quality devices.

Quality Manuals: Outline the foundation of the company’s Quality System. They describe the overview of processes such as design, development, and surveillance both pre- and post- market.

Quality Records: Documents that detail the history of actions taken to maintain regulatory compliance. When completing Quality Documents, Records, Travelers, or Test Records, each document must be completed according to Good Documentation Requirements (see above). A good rule of thumb is: “If it’s not documented, it didn’t happen.”

Risk Management: One of the most important aspects of a QMS, its purpose is to identify hazards associated with the medical devices through Preliminary Hazard Analysis (PHA), estimate and evaluate the associated risks, reduce said risks to the lowest possible level, and then monitor the eﬀectiveness of the implemented controls. Once risks are identified, they are then reviewed through the lenses of Design, Use, Process and Software.

SaMD: Software as a Medical Device. A class of medical software designed to carry out one or more medical functions without the need for actual hardware.

SOR/98-282: The Canadian Medical Devices Regulations. Manufacturers selling medical devices in Canada must ensure that their medical devices meet the safety and eﬀectiveness requirements as defined in this regulation.

Traceability: How companies track their products once they’ve been sold into the marketplace. Traceability Serial/batch numbers are required for all finished devices and components within device.

Verification Testing: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.