Medical Device Design: 50 Words in the Medical Industry


Every industry has its own oral terminology, as does the medical industry, and your knowledge of medical device terminology enables you to work efficiently, communicate clearly and reduce errors and misunderstandings when designing, developing, manufacturing and selling medical devices.

As we all know, there are many professional terms in the medical device industry, many of which are directly used in English alphabetic abbreviations, which may sometimes confuse everyone. Below we have shared common medical device acronyms and definitions so that you can grasp them more easily.

1)21 CFR Part 820 (21 CFR PART 820)

FDA maintains the Quality System Regulation, or QSR, in 21 CFR Part 820, which establishes quality system requirements for all medical device manufacturers in the United States. According to the requirements of 21 CFR Part 820, manufacturers need to establish and maintain a quality system applicable to medical devices to ensure the safety and effectiveness of their intended use.

  2)CE标志(CE MARKING/CE MARK)

Medical device manufacturers must obtain CE marking or CE mark certification in order to distribute their products to the European Union (EU) market. The CE marking is issued by a third-party organization (I. e. a Notified Body) to indicate compliance with the applicable EU medical device regulations.

3) European Committee for Standardisation (CEN-EUROPEAN COMMITTEE FOR STANDARDIZATION)

The European Committee for Standardization (CEN) is a public standards organization responsible for setting standards for medical devices sold in the European Union (EU).

4)510 (k) Pre-Market Notification

510(k) is a regulatory premarket submission to the FDA for a Class I, II, or III medical device that does not require premarket approval. 510(k) The purpose of the submission must demonstrate a safe and effective product that is substantially equivalent to an existing legally marketed product.

5) Clinical evaluation report (CER-CLINICAL EVALUATION REPORT)

The clinical evaluation report provides clinical evidence that the medical device will perform as expected, so that there will be no safety issues when used. European regulations require medical device manufacturers to carry out a conformity assessment, including a CER file, in order to legally sell products in the EU.

6) Pre-market approval (PMA-PREMARKET APPROVAL)

Premarket approval is the regulatory path required by the FDA to market Class III devices. The PMA submission process typically involves clinical trials with human participants as well as laboratory testing to demonstrate the safety and effectiveness of the device.

  7)上市后监督(PMS-POST-MARKET SURVEILLANCE)

Post-marketing monitoring refers to the process of monitoring medical devices after they enter the market for use by patients in the market. PMS involves collecting data and feedback on the performance of equipment in the market and is a mandatory process for compliance with most regulations and standards, including 21 CFR Part 820, EU MDR and ISO 13485:2016.

  8)IEC 60601

IEC 60601 is a standard related to electrical medical devices. Any medical device containing electronic equipment must pass the necessary requirements outlined in IEC 60601.

Programmable Electrical Medical Systems (PEMS) is a key part of IEC 60601. A PEMS consists of software, firmware, and instrumentation that can be programmed to perform functions that facilitate medical care or treatment. The standard also includes machinery safety, labeling and risk management.

  9)IEC 62304

IEC 62304 is a software framework that provides an overview of software engineering and documentation practices. It is also recognized by the FDA and provides a risk-based framework that can be used throughout the medical device software lifecycle.

  10)国际标准化组织(ISO-INTERNATIONAL ORGANIZATION FOR STANDARDIZATION)

The International Organization for Standardization (ISO) is an expert, non-governmental organization that provides voluntary international standards based on the subject matter expertise of its members to support and promote innovative solutions to global challenges.

  11)ISO 13485:2016

ISO 13485:2016 is the internationally harmonized standard for quality management systems (QMS) for medical devices. In order to be consistent with ISO 13485:2016, QMS content should meet the specific applicable requirements outlined in the standard, as well as the applicable regulatory requirements in the markets in which medical devices are manufactured and distributed.

  12)ISO 14971:2019

ISO 14971:2019 is the latest version of the international standard for risk management of medical devices. Globally recognized standards provide best practices for using a proactive risk management approach throughout the life cycle of a medical device.

  13)ISO 9001

ISO 9001 is an international standard that specifies the requirements for a quality management system. According to ISO 9000, 9001 is the only standard that provides a certification pathway for manufacturers, with a focus on ensuring that users receive quality products and services.

14) Designed for manufacturing (DFM-DESIGN FOR MANUFACTURE)

Design for manufacturing is the process of optimizing the design of medical device manufacturing. DFM considers manufacturing costs, regulatory compliance, and product performance.

15) Design History File (DHF-DESIGN HISTORY FILE)

The design history file contains all documents related to the design and development of the medical device. According to FDA 21 CFR Part 820, manufacturers of medical devices in the US market are required to maintain DHF.

16) Device History (DHR-DEVICE HISTORY RECORD)

The device history record is used as a manufacturing record for a medical device and proves that it was manufactured based on information stored in the device master record (DMR). CFR Part 820.184 requires manufacturers operating in the United States to maintain a DHR, which contains information such as acceptance records for units or lots of products, unique product identifiers, and product counts.

17) MASTER RECORD (DMR-DEVICE)

A device master record is a record of all information and specifications required to produce a medical device. The DMR contains manufacturing instructions, equipment drawings and specifications, and labeling and packaging requirements. The FDA requires manufacturers to maintain the DMR in accordance with CFR Part 820.181.

18) Document Management System (DMS-DOCUMENT MANAGEMENT SYSTEM)

The document management system is a tool for storing and managing documents related to the development of medical devices, and continuously tracks any changes to the documents throughout the product life cycle. DMS is not synonymous with a quality management system (QMS), which stores documentation but also has a regulatory compliance focus.

  19)在制品(WIP-WORK IN PROGRESS)

In-process is a term used to refer to a part of the finished product in the manufacturing process or in the design history record (DHR). Inventory that has entered the manufacturing process and can no longer be classified as raw materials but has not yet become finished goods is classified as work in progress.

20) Risk analysis (RA-RISK ANALYSIS)

Risk analysis is a method used in risk management to identify specific risks associated with designs, procedures, or processes used in the manufacture of medical devices. The risk assessment process will include the identification of the medical device, the persons involved, the scope of the risk analysis and the relevant dates. Preliminary Hazard Analysis, FMEA, and Fault Tree Analysis are all methods used to perform risk analysis on medical devices.

21) Risk Management (RM-RISK MANAGEMENT)

Risk management is the process used by medical device companies to identify, control and prevent hazards and sources of risk/injury that may occur during the use of medical devices. ISO 14971:2019 provides an overview of internationally recognized standards for medical device RM processes.

22) FMEA (FMEA-FAILURE MODES AND EFFECTS ANALYSIS)

Failure mode and effects analysis is a method used to identify failures in the design or process related to medical devices. FMEA is different from ISO 14971, the international standard for risk management of medical devices. The FMEA method can be divided into two parts: process PFMEA and design DFMEA.

23) Fault Tree Analysis (FTA-FAULT TREE ANALYSIS)

Fault tree analysis is an analytical method designed to identify points of failure and risks in a quality system. In the medical device manufacturing industry, FTA can be applied to the entire process of risk management activities to identify possible sources of risk.

  24)体外诊断法规(IVDR-IN VITRO DIAGNOSTIC REGULATION)

The European Commission's new IVDR 2017/746, short for In Vitro Diagnostics Regulation, is a new European regulation for in vitro diagnostic devices, which is scheduled to enter into force in May 2022. The IVDR requires all existing IVD devices sold on the EU market to be re-certified to comply with the new requirements, which replaces the previously held In Vitro Diagnostic Devices (IVDD) Directive.

25) Research purposes (RUO-RESEARCH USE ONLY)

Research only is a technical term used to indicate that a medical device product or instrument does not have the intended medical use, but is used only for research purposes. Equipment used for IVD product development research is usually labeled RUO.

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Medical Device Design: 50 Words in the Medical Industry

Every industry has its own oral terminology, as does the medical industry, and your knowledge of medical device terminology enables you to work efficiently, communicate clearly and reduce errors and misunderstandings when designing, developing, manufacturing and selling medical devices.


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