The medical device industry is filled with its own jargon. Here’s a list of terms you may need as you’re getting up to speed.
CE Mark – A CE Mark is a conformity mark that indicates that a medical device meets the requirements of the relevant European Union (EU) directive.
Clinical trial – A clinical trial is a research study that is conducted to evaluate the safety and effectiveness of a medical device in humans.
FDA – The Food and Drug Administration is a federal agency that is responsible for regulating the safety and effectiveness of medical devices in the United States.
Good Manufacturing Practices (GMP) – Good Manufacturing Practices are guidelines that outline the minimum standards that must be met in the production, testing, and quality control of medical devices.
In vitro diagnostic (IVD) – An in vitro diagnostic is a medical device that is used to perform tests on samples of body fluids or tissues.
ISO 13485 – ISO 13485 is an international standard that outlines the requirements for a quality management system specifically for the design and manufacture of medical devices.
Key opinion leader (KOL) – A key opinion leader is a respected healthcare professional who is influential in their field and can help to promote a medical device to other healthcare professionals.
Market access – Market access refers to the ability to sell a medical device in a particular market or country.
Market segmentation – Market segmentation is the process of dividing a market into smaller groups of consumers with similar needs or characteristics.
Marketing authorization – Marketing authorization is the permission granted by a regulatory body to sell a medical device in a particular market or country.
Medical device data systems (MDDS) – Medical device data systems are devices that are used to transfer, store, or display medical device data.
Pre-market approval (PMA) – Pre-market approval is a regulatory process that must be completed before a medical device can be sold in the United States.
Post-market surveillance – Post-market surveillance is the monitoring of a medical device after it has been placed on the market to identify any potential safety issues or adverse events.
Product launch – A product launch is the introduction of a new medical device to the market.
Quality management system (QMS) – A quality management system is a set of policies, procedures, and processes that are used to ensure the quality of a medical device.
Regulatory affairs – Regulatory affairs is the department within a company that is responsible for ensuring that a medical device complies with all relevant regulatory requirements.
Reimbursement – Reimbursement refers to the process of health insurance providers paying for medical devices or procedures.
Risk management – Risk management is the process of identifying, evaluating, and mitigating the risks associated with a medical device.
User needs – User needs are the requirements or expectations of the individuals who will be using a medical device.
510(k) clearance – In the United States, medical devices that are classified as moderate-risk (Class II) must obtain 510(k) clearance from the FDA before they can be marketed. This clearance demonstrates that the device is substantially equivalent to another device that is already on the market.
This glossary was created with the help of ChatGPT.