Working in the MedTech industry involves interconnecting many areas of expertise that range from product development to regulatory affairs in order to create a successful and marketable outcome. In order to communicate effectively with other colleagues, it is important to acquaint yourself with common terminology. The following are useful definitions from a variety of different topics such as FDA approvals, software, ISO standards, and much more.
1. Medical Technology (MedTech)
The application of science to develop solutions to health problems or issues such as the prevention or delay of onset of diseases or the promotion and monitoring of good health
The use of technologies developed for the purpose of improving any and all aspects of the healthcare system. From telehealth to robotic-assisted surgery, our guide will walk you through what it is and how it's being used.
The convergence of digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and to make medicine more personalized and precise.
Biotechnology is technology based on biology - biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet.
5.Medical Device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery.
6.Clinical Trial
Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
7.CRO
A Contract Research Organization, also called a Clinical Research Organization, is a service organization that provides support to the pharmaceutical and biotechnology industries. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research and development process.
8.Computer-Aided Design (CAD)
Computer-Aided Design (CAD) software allows device manufacturers and designers to draft detailed designs, including precise specifications and measurements. CAD software files can be stored on a digital database for reference.
9.MDD
The Medical Device Directive is intended to harmonize the laws relating to medical devices within the European Union. Medical Device Directive 93/42/EEC was most recently reviewed and amended by 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
10.FDA
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
11.Notified Body
A Notified Body, or NB, is a third-party auditing organization that assesses the quality and conformity of medical device products seeking market entry into the European Union.
12.510(k)
One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a510(k) with the Food and Drug Administration (FDA). Also known as a "Premarket Notification" a 510(k) notification allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Any device that reaches market via 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device").
13.PMA
Premarket approval by FDA is the required process of scientific review to guarantee safety and effectiveness for Class III devices.
14.CE Marking
The CE Marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. By affixing the CE marking to a product, the manufacturer declares that it meets EU safety, health and environmental requirements.
15.De Novo
The De Novo regulatory pathway is a classification process that uses a risk-based methodology for novel medical device to be granted market entry for sale in the U.S. For a de novo submission to be granted by FDA, general controls must indicate that the device is safe and effective for its intended use.
16.Validation
Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.
17.Quality Assurance
Prevents flaws in the way a medical device is manufactured. Quality assurance happens throughout the medical device manufacturing process. Quality staff look for problems in processes that might result in nonconforming products, and fix those processes that would otherwise cause defects. The primary focus of quality assurance is the process.
18.Quality Control
Finds flaws in products after they’ve been manufactured but prior to distribution into the marketplace. Quality control tests products or batches of products to see whether they conform to product specifications. The primary focus of quality control is the product.
19.QMS
A Quality Management System, or QMS, is an organizational tool for implementing and maintaining activities, documents, and tasks as it relates to responsibilities, procedures, processes, and resources. A QMS is instrumental in achieving regulatory compliance and in producing safe and effective medical devices. At minimum, a quality system should include design controls, risk management, document control and records management, and supplier management.
20.Verification And Validation (V&V)
Verification and Validation, also known as V&V, are activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture. Design verification ensures you designed the device correctly and design validation ensures you designed the correct device. These processes tend to involve careful tests, trials, and analyses.
21.Corrective And Preventative Action (CAPA)
Corrective and Preventive Action, or CAPA, is a quality system process carried out by a medical device organization to reduce and/or eliminate potential sources of risk and regulatory non-conformance or noncompliance.
22.Regulatory Affairs (RA)
Profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
23. IDE
An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
24.ISO 14971
ISO 14971 is an ISO standard, published in 2007, that represents the requirements for a risk management system for medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.
25.ISO 9001
ISO 9001 is an ISO standard that represents the requirements for quality management systems. It is used across industries and is not specific to medical devices like ISO 13485.
26.ISO 13485
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.
27.Technical File
A Technical File (called a Design Dossier for Class III devices) is a comprehensive collection of documents that demonstrates a product's technical basis for conformity to the applicable directive(s). It is required by the CE Marking Directive.
28.Warning Letter
A warning letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.
29.Freedom To Operate (FTO)
Freedom to Operate, or FTO, refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product.
30.In Vitro Diagnostic (IVD) Devices
IVD refers to In Vitro Diagnostic devices. As defined in IVDR (EU) 2017/746, IVD can describe devices or equipment “intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”
31.Original Equipment Manufacturer (OEM)
An Original Equipment Manufacturer, or OEM, is an organization that produces goods which are used as subparts in products of a third-party company, which then sells the end products to consumers.
32.Product Development (PD)
Product Development, or PD, is the pre-market process of building a medical device. In the medical device industry, this process encompasses the design and development of a product.
The payment a third party public or private insurer pays a health care provider for costs or payments the provider incurred while using a medical device or performing a procedure. Coding, coverage and payment for a specific medical technology.