IEC 81001-5-1: A Cybersecurity Pathway for FDA and MDR Compliance
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Regulatory bodies require manufacturers to implement cybersecurity measures during design and development stages.
Christopher Gates, Director of Product Security, Velentium 07.20.23
The Health Sector Coordinating Councilâs (HSCC) Joint Security Plan (JSP) v1 January 2019
IEC 62443-4-1: 2018 Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements
Section 4: General requirements
Section 5: Software development process
Section 6: Software maintenance process
Section 7: Security risk management process
Section 8: Software configuration process
Section 9: Software problem resolution process
Section 5.1: Software development planning
Section 5.2: Health software requirements analysis
Section 5.3: Software architectural design
Section 5.4: Software design
Section 5.5: Software unit implementation and verification
Section 5.6: Software integration testing
Section 5.7: Software system testing
Section 5.8: Software release
Velentium
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Login Join. FOLLOW: Subscribe Free Magazine eNewsletter Checkout. Magazine. News. Opinions. Top 30. Research. Supply Chain. Device Sectors. Directory. Events. Resources. Microsites. More. Magazine. News. Opinions. Top 30. Research. Supply Chain. Device Sectors. Directory. Events. Resources. Microsites. Current / Back Issues. Features. Editorial. Digital Edition. eNewsletter Archive. Our Team. Editorial Guidelines. Reprints. Subscribe Now. Advertise Now. Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing. How Medical Device Interoperability Connects Healthcare. 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing. A Combined Effort for Drug Delivery & Combo Product Technology. Examining Medical Packaging & Sterilization on Multiple Fronts. OEM News. Supplier News. Service / Press Releases. Online Exclusives. Press Releases. People in the News. Product & Service Releases. Supplier News. Medtech Makers. Technical Features. International News. Videos. Product & Service Releases. Live From Shows. Regulatory. Financial/Business. Veristat Welcomes Three New Leaders to Executive Team. MedAccred Program Joins Irradiation Industry Association. FDA OKs Updated BD Alaris Infusion System After Long Commercial Hold. FDA Clears Acurable's Sleep Apnea Testing Device. Nesa Medtech's Fibroid Mapping Reviewer Application Gains FDA Nod. From the Editor. Blogs. Guest Opinions. Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing. How Medical Device Interoperability Connects Healthcare. 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing. A Combined Effort for Drug Delivery & Combo Product Technology. Examining Medical Packaging & Sterilization on Multiple Fronts. Top 30 Medical Device Companies. Market Data. White Papers. A Darwinist Take on the Evolution of Med Device Quality (Part 1) Is Medtech Ready for âMedGPTâ? 5 Lessons Learned from Navigating Medtech Supply Chain Narrative Firestorms. MPO Top 30: M&A Scorecard Since 2022. 3D/Additive Manufacturing. Contract Manufacturing. Electronics. Machining & Laser Processing. Materials. Molding. Packaging & Sterilization. R&D & Design. Software & IT. Testing. Tubing & Extrusion. Cardiovascular. Diagnostics. Digital Health. Neurological. Patient Monitoring. Surgical. Orthopedics. All Companies. Categories. Company Capabilities. Add New Company. LEMO USA Inc. Cirtec Medical. JBC Technologies. Medbio LLC. Johari Digital Healthcare Ltd. MPO Summit. Industry Events. Webinars. Live From Show Event. Industry Associations. Videos. Career Central. eBook. Slideshows. Enhancing Safety in Medical Device Manufacturing: The Power of Connected Worker Technology. 4 Things to Look for When Considering a Supply Chain Partner. Adhesive Bonding Without Traditional Clamping. Best Practices to De-Risk the Medical Device Supply Chain. Mitigating Cybersecurity Risks in Medical Device Development. Companies. News Releases. Product Releases. Press Releases. Product Spec Sheets. Service Releases. Case Studies. White Papers. Brochures. Videos. LEMO USA Inc. Cirtec Medical. JBC Technologies. Medbio LLC. Johari Digital Healthcare Ltd. Magazine Current/Back Issues Features Editorial Columns Digital Editions Subscribe Now Advertise Now. News. Directory All Companies ALL CATEGORIES Industry Associations Company Capabilities Add Your Company. Supply Chain 3D/Additive Manufacturing Contract Manufacturing Electronics Machining & Laser Processing Materials Molding Packaging & Sterilization R&D & Design Software & IT Testing Tubing & Extrusion. Device Sectors Cardiovascular Diagnostics Digital Health Neurological Patient Monitoring Surgical Orthopedics. Top 30 Company Report. Expert Insights. Slideshows. Videos. eBook. Resources. Podcasts. Infographics. Whitepapers. Research White Papers Case Studies Product Spec Sheets Market Data. MPO Summit. Events Industry Events Live From Show Events Webinars. Microsite Companies Product Releases Product Spec Sheets Services White Papers / Tech Papers Press Releases Videos Literature / Brochures Case Studies. About Us About Us Contact Us Advertise with Us eNewsletter Archive Privacy Policy Terms of Use. Regulatory bodies require manufacturers to implement cybersecurity measures during design and development stages. Christopher Gates, Director of Product Security, Velentium 07.20.23. The Health Sector Coordinating Councilâs (HSCC) Joint Security Plan (JSP) v1 January 2019. IEC 62443-4-1: 2018 Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements. Section 4: General requirements. Section 5: Software development process. Section 6: Software maintenance process. Section 7: Security risk management process. Section 8: Software configuration process. Section 9: Software problem resolution process. Section 5.1: Software development planning. Section 5.2: Health software requirements analysis. Section 5.3: Software architectural design. Section 5.4: Software design. Section 5.5: Software unit implementation and verification. Section 5.6: Software integration testing. Section 5.7: Software system testing. Section 5.8: Software release. Velentium. Related Searches. Software & IT. Software & IT. Former Employee Of Medical Device Firm Admits Forging FDA Clearance Letters. A New Approach To Post-Market Surveillance. Philips Partners With Polarea To Advance Ventilation Imaging. FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech. Philips Names New Supervisory Board Chairman. Breaking News. Veristat Welcomes Three New Leaders to Executive Team. MedAccred Program Joins Irradiation Industry Association. FDA OKs Updated BD Alaris Infusion System After Long Commercial Hold. FDA Clears Acurable's Sleep Apnea Testing Device. Nesa Medtech's Fibroid Mapping Reviewer Application Gains FDA Nod. View Breaking News >. CURRENT ISSUE. July/August 2023. Sustainability Initiatives for Medtech Manufacturing. How Medical Device Interoperability Connects Healthcare. View More >. Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More informationâ. Got It. About Us. Privacy Policy. Terms And Conditions. Contact Us. follow us. Subscribe. Latest Breaking News From Nutraceuticals World. Keurig Dr. Pepper Enters Partnership with La Colombe. FDA Rejects Request to Hold Public Hearing on NMN. Bill Introduced to Cover Dietary Supplements in HSA/FSA Accounts. Latest Breaking News From Coatings World. Chris Roberts Joins PPG Board of Directors. HOFFMANN MINERAL Introduces New Filler. BASF Production Operator First to Complete Apprenticeship Program at Sparta, TN Site. Latest Breaking News From Medical Product Outsourcing. FDA OKs Updated BD Alaris Infusion System After Long Commercial Hold. FDA Clears Acurable's Sleep Apnea Testing Device. Nesa Medtech's Fibroid Mapping Reviewer Application Gains FDA Nod. Latest Breaking News From Contract Pharma. Roche, Alnylan Enter $310M Zilebesiran Development Pact. Cognizant, Gilead Extend Partnership with $800M IT Service Agreement. Curia Expands Capabilities with Access to Touchlightâs Doggybone DNA. Latest Breaking News From Beauty Packaging. Barbie Fragrance To Launch in August. Kiehlâs Introduces Truly Targeted Acne-Clearing Solution. Johnson & Johnson to Split Off Kenvue Through Exchange Offer. Latest Breaking News From Happi. Kiehl's Releases New Truly Targeted Acne-Clearing Solution. Tarte Promotes Staff to Key Finance, Supply Chain Roles. Nails.Inc x Froot Loops Launch Nail Polish Duo Collection. Latest Breaking News From Ink World. Flint Group to Exhibit at Labelexpo Europe 2023. Weekly Recap: Carl Hirsch, Flint Group Top This Week's Stories. BASF and Mingyang Form JV for Offshore Wind Farm in South China. Latest Breaking News From Label & Narrow Web. Lansen Label adds ArrowJet Aqua 330R Lite. Mike Cooper receives AWA leadership recognition. Label Source profiled, TLMI hosts LLT event and more. Latest Breaking News From Nonwovens Industry. Weekly Recap: Private Equity Firms Buy Ecowipes, Essity Exits Russian Market & More. WOW 2023 Breaks Attendance Records. Neutrogena Launches Compostable Makeup Wipes. Latest Breaking News From Orthopedic Design & Technology. Cerapedics Expanding its Headquarters. ODT's Most-Read Stories This WeekâJuly 22. Relievant Shares 4-Year Positive Data on Intracept Ablation Procedure. Latest Breaking News From Printed Electronics Now. 3D-Micromac Announces Breakthroughs for Laser Micromachining. Butler Technologies Launches Printed Heater Development Kit. Weekly Recap: Energix and First Solar, ASSA ABLOY, Impinj Top This Weekâs Stories. Copyright © 2023 Rodman Media. All rights reserved. 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