Webcombination products are referred to as “constituent parts” of the combination product. Under 21 CFR 3.2(e), a combination product includes: • A product comprised of two … WebDec 17, 2024 · Final Thoughts. The device master record is a regulatory requirement for all medical device companies. It is a repository of all essential information about your company’s medical devices and includes design requirements, production requirements, quality assurance requirements, packaging and labeling specifications, and other records.

Design History File, Device Master Record, Device History Record

WebThis includes successful Design History File Remediation and Process Improvements for Medical devices and Combination Products. Learn more about Lori-Ann Archer, CQE, CMDA, CSQE's work ... WebFeb 16, 2016 · As you design, engineer and manufacture your combination product, one of the most important parts of the FDA’s regulatory process is the design history file … helen thorpe close brothers

Drug Device Combination Products - Operon Strategist

WebJul 1, 2024 · Verification and Design Validation Introduction A combination product (CP) is basically defined by the US Food and Drug Administration (FDA) as 2 or more different … WebA combination product is defined as anything that: under 21 CFR 3.2 (e), includes: a product made up of two or more regulated components (e.g., a drug and a device, a biologic and a device, or a drug and a biological and a device) that are physically, chemically, or otherwise joined or mixed and created as a single entity; a combination … WebOct 7, 2024 · The medical device industry has a lot of acronyms. The terms DHF, DMR, and DHR (which stand for Design History File, Device Master Record, and Device History Record, respectively) have had associations with design controls for some time now, but the similarity of letters in each respective name is enough to cause ongoing confusion … helen tomblin