A Guide To UDI Device Label And Package Requirements
WEBNov 24, 2014 · Learn how to comply with the unique device identification (UDI) rule that requires device manufacturers to assign and communicate a device identifier (DI) and production identifiers (PI) to FDA and customers. Find out the formats, data carriers, date standards, packaging configurations, and direct marking options for different devices.
ISO TR 249712020 — Bringing Clarity To Risk Acceptability In ISO …
WEBNov 19, 2020 · Annex A of ISO TR 24971:2020 provides extensive guidance on how to define and document a policy for establishing criteria for risk acceptability in ISO 14971:2019. It explains the approaches to risk control, the terms "benefit" and "benefit-risk analysis", and the common misinterpretations and mistakes to avoid.
ISO 10993-23 The “Step-Wise” Approach To Evaluate Potential …
WEBMay 12, 2021 · Learn about the latest ISO standard for evaluating the irritating potential of medical devices, materials, or their extracts. Find out how to use the step-wise approach, the in vitro test method with reconstructed human epidermis, and …
FDA Releases Guidance On Cybersecurity In Medical Devices
WEBMay 31, 2022 · Learn how the FDA expects medical device manufacturers to apply cybersecurity principles and practices throughout the product life cycle. The guidance covers devices that contain software, programmable logic, or SaaMD and aligns with NIST's Secure Software Development Framework.
The Role Of The Contract Manufacturer Under The EU MDR & IVDR
WEBMay 31, 2021 · Learn how contract manufacturers can comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) as economic operators. Find out the key requirements for quality agreements, audits, records, risk management, validations, and traceability.
ISO 149712019 — Clarifying Benefit Risk Benefit-Risk - Med …
WEBFeb 8, 2021 · Learn about the changes and clarifications in the ISO 14971 standard for medical device risk management, including the terms benefit and risk. Find out how to perform benefit-risk analysis and align with regulatory requirements.
Medical Device Regulations & Compliance - Med Device Online
WEBMedical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 and subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938. The FDA’s medical device regulatory pathways — …
Medical Device Manufacturing - Med Device Online
WEBLearn about the latest trends, challenges, and best practices in medical device manufacturing from experts and peers. Find white papers, case studies, products, and services to help you design, develop, and produce high-quality devices.
Attribute Vs Variable Testing For Device Functionality What They …
WEBNov 24, 2021 · Learn the difference between attribute and variable testing for medical device functionality, when to use which, and how to design optimal test setup. Attribute testing is a pass/fail type of test, while variable testing is a statistical analysis of test results.
Understanding The New MHRA Requirements For Medical Devices …
WEBOn Jan. 9, 2024, the MHRA revealed a road map for medical device regulation, aiming to prioritize patient safety and establish a new framework by 2025. The new framework includes a focus on implantable devices, artificial intelligence, cybersecurity, and early disease detection diagnostics. By introducing new regulations, the agency aims to ...