Med Device Online: Advancing human health by connecting …
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established …
A Brief Guide To ISO 13485's Design Controls In Medical Device …
Sep 15, 2023 · Design And Development Planning: ISO 13485 emphasizes the importance of planning the design and development process. It helps to create a comprehensive design and …
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 …
FDA Releases Guidance On Cybersecurity In Medical Devices
May 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 …
The Role Of The Contract Manufacturer Under The EU MDR & IVDR
May 31, 2021 · Conclusion. The relationship between the contract manufacturer and the manufacturer (specification holder) under the EU MDR and IVDR will be much more …
ISO TR 249712020 — Bringing Clarity To Risk Acceptability In ISO …
Nov 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 …
What Does EN ISO 149712019's New Amendment Mean For …
Mar 4, 2022 · With harmonisation, EN ISO 14971:2019 will become the only standard for medical device risk management in the EC and has already replaced the previous harmonised EN ISO …
Key Considerations In "Intended Use" And "Indications For Use ...
Dec 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 …
Understanding The New MHRA Requirements For Medical Devices …
On 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 …
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 …