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Website. cdsco.gov.in and www.cdscoonline.gov.in. The Central Drugs Standard Control Organisation (CDSCO) is India 's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements. For instance, a regulatory agency (such as CE or FDA) may ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
The design of medical devices constitutes a major segment of the field of biomedical engineering. The global medical device market was estimated to be between $220 and US$250 billion in 2013. [4] The United States controls ≈40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%).
Community portal; Recent changes; Upload file; Search. Search. Create account; Log in; Personal tools. ... Validation and verification (medical devices) Retrieved ...
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.