FDA Clears Robotic Surgical System - Med Device Online
WEBJul 12, 2000 · FDA Clears Robotic Surgical System. The U.S. Food and Drug Administration has approved the first completely robotic surgical system for sale in the United States. The da Vinci surgical system, designed for use in laparoscopic procedures, is manufactured by Intuitive Surgical Inc. (Mountain View, CA).
FDA Releases Guidance On Cybersecurity In Medical Devices
WEBMay 31, 2022 · The FDA’s medical device cybersecurity guidance would require that manufacturers’ devices with software, firmware, or programmable logic, as well as software as a medical device (SaMD), minimize the cybersecurity risks associated with the design, safety, and use of those devices. Manufacturers would have to …
Abbott Completes 25 Billion Purchase Of St Jude Medical - Med …
WEBJan 6, 2017 · Abbott Laboratories has formally completed its $25 billion acquisition of St. Jude Medical to add a chronic pain management business and significantly bolster its cardiovascular device offerings. The deal makes St. Jude a wholly-owned subsidiary of Abbott, which is now considered a major player in …
ISO TR 249712020 — Bringing Clarity To Risk Acceptability In ISO …
WEBNov 19, 2020 · The resulting revision of ISO TR 24971:2013 — ISO TR 24971:2020 — provides extensive guidance in the informative annexes, discussions of the requirements in ISO 14971:2019, and further discussion of the terms “benefit” and “benefit-risk analysis.”. It does not add any requirements. It is only guidance or help for those implementing ...
A Guide To UDI Device Label And Package Requirements
WEBNov 24, 2014 · A Guide To Device, Label, And Package Requirements Of The UDI Rule. By Dan O'Leary, President, Ombu Enterprises. On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they ...
Med Device Online: Advancing human health by connecting …
WEBThe U.S. market is continuing its shift away from traditional wound dressings (gauze, tape, etc.) toward advanced wound care (moist dressings, antimicrobial dressings, etc.).
ISO 149712019 — Clarifying Benefit Risk Benefit-Risk - Med …
WEBFeb 8, 2021 · <p>This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.</p>
Medtech Manufacturing Elastomer Gaskets For Injection And …
WEBAug 12, 2015 · In medical engineering and in the pharmaceutical industry, elastomer gaskets are often used for injection and infusion systems in order to guarantee the integrity of the medication in the primary packaging. This article examines how different materials and production processes are leveraged to meet product- and …
Medical Device Packaging Labels 101 - Med Device Online
WEBMar 16, 2022 · A device manufacturer selling in the United States must follow 21 CFR Part 801. ISO 15223: Just revised in 2021, ISO 15223-1 details the symbols to use on medical device labels. ISO 15223-2 details symbol development, selection, and validation, and provides additional information on choosing symbols. While the …
Key Considerations In "Intended Use" And "Indications For Use ...
WEBDec 14, 2023 · 1. How — And When — The Terms Will Be Used. “Intended use” is paramount in deciding whether a product qualifies as a medical device. It’s also a major determinant of risk classification for a device. “Indications for use” have additional roles, particularly in setting the regulatory path of a device. If you designate a scalpel ...
Skip to content