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IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

leoeisner May 6, 2024May 6, 2024 14971, 15223-1, 20417, 60601 Series, 60601-1, 60601-1-10, 60601-1-11, 60601-1-12, 60601-1-6, 60601-1-8, 60601-1, 4th edition, 62304, 62366, 62366-1, AAMI, Alarm Systems, Architecture Specification, Coexistence, Cybersecurity, Design Specification, Device, Draft Guidance, EMC, Essential Performance, EU, FDA, Guidance Documents, Hazards, IEC, IEC 60601-1, IMDRF, Information provided by the manufacturer, Interpretation Sheet 1, Ionizing radiation, ISH1, ISO, ISO 15223-1, ISO 20417, Labeling, Machine Learning, Marking, May 2024, MDD, MDR, Mechanical, Medical Device, Medical Device Regulation, MHRA, Notified Bodies, PEMS, Physiologic Closed-Loop Control, Regulation, Regulatory Affairs, Risk Management, SaMD, SiMD, Single Fault Condition, Software, Standards, Standards Development, State of the Art, UDI, Usability, Usability Engineering Process, User Interfaces Read more

Draft EUDAMED Roadmap of Modules

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

leoeisner October 21, 2023October 21, 2023 13485, 14971, 15223-1, 60601 Amendments, 60601 Series, 60601-1, 60601-1 A2, 60601-1 Amendment 2, 60601-1-10, 60601-1-11, 60601-1-12, 60601-1-2, 60601-1-2, 4th ed., 60601-1-6, 60601-1-8, 60601-1-9, 62304, 62366, 62366-1, Active Implants, Auditing, Combination Product, Cybersecurity, Device, EMC, Essential Performance, EU, EU Commission, EUDAMED, ISO 15223-1, IVDR, Labeling, Marking, MDCG, MDR, Medical Device, Medical Device Regulation, Notified Bodies, Oct 2023, Regulation, State of the Art, UDI Read more

June International Regulatory Updates

June International Regulatory Updates for Canada, Saudi Arabia, EU, & US

leoeisner June 30, 2022July 1, 2022 60601 Series, 60601-1, 60601-1-2, Cybersecurity, EU, FDA, Health Canada, IEC, June 2022, MDR, Saudia Arabia, Standards, UDI, US Read more

Regulatory Updates – January 2022

Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world

leoeisner January 31, 2022June 12, 2022 Active Implants, Brexit, Combination Product, Computational Modeling, Computational Simulation, Designated Standards, Device, Draft Guidance, FDA, Final Guidance, Guidance Documents, Hamonised Standards, IVD, IVDR, Jan 2022, MDR, Medical Device Regulation, Patient Engagement, Patient Reported Outcome Instruments for Use in Medical Device Evaluation, Physiologic Closed-Loop Control, Recognized Consensus Standards, Reprocessing, Scotland, Software, Standards, UDI, UK, Wales Read more

Categories – Drop Down

Categories – Hot Topics

510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC 60601-1 IEC60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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