Key Considerations In "Intended Use" And "Indications For Use ...
Dec 14, 2023 · <p>You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.</p>
Understanding The New MHRA Requirements For Medical Devices …
Apr 9, 2024 · Recent developments at U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) as a result of EU MDR extensions and other factors have caused the agency to update its transition arrangement dates for CE marked devices.
A Brief Guide To ISO 13485's Design Controls In Medical Device …
Sep 15, 2023 · The development of medical devices requires meticulous attention to detail and a focus on ensuring patient safety. Design controls play a crucial role in the development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities, and ensuring that devices are designed, developed, and manufactured in a consistent and controlled ...
Med Device Online: Advancing human health by connecting …
The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.
ISO 10993-23 The “Step-Wise” Approach To Evaluate Potential …
May 12, 2021 · <p>The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless …
ISO 149712019 — Clarifying Benefit Risk Benefit-Risk - Med …
Feb 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 …
Attribute Vs Variable Testing For Device Functionality What They …
Nov 24, 2021 · <p data-pm-slice="1 1 []">Testing performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the strategic approaches to ...
Regulatory Requirements For A Clinical Investigation For Medical ...
Jan 24, 2022 · <p data-pm-slice="1 1 []">On May 26, 2021, the Regulation EU 745/2017 (MDR) entered into force. A clinical investigation must be performed for novel implantable and Class III medical devices to demonstrate that the device is compliant with the general safety and performance requirements. This article also discusses related guidance from the Medical Device Coordination Group.</p>
5 Key Steps For FDA Q-Submissions - Med Device Online
Apr 18, 2022 · <p data-pm-slice="1 1 []">Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.</p>
DSM Biomedical - Med Device Online
DSM Biomedical is a global leader in biomedical materials science with experience in creating advanced drug delivery technologies. Their proprietary bioresorbable polymers provide the foundation that enables biopharmaceutical companies to formulate implantable drug delivery systems for specific applications.