Establishing security inputs during medical device design and coding phases not only lays the foundation for security against the most common vulnerabilities, but also reduces future costs, as fixing problems at a later stage is more costly. Regardless of the development methodology used, the definition of security controls should start at the design stage, and continue throughout the product lifecycle to ensure that the medical device will continue to have the relevant security measures in case of changes to the initial arrangement due to business or patient needs. #fda #medicaldevice #designcontrol #quality #regulatory #510k #cybersecurity
关于我们
CyberActa is a boutique consultancy empowering companies in their cybersecurity, privacy, data integrity, regulatory compliance, and commercialization endeavors. We assist on matters spanning the product life cycle, from product development and clinical trials, through the FDA, EMA, PMDA, and TGA premarket review processes, to post-market compliance, GxP practices, software validation, and Quality System requirements. Whether traditional medicinal products and devices, rapidly evolving medical and health technology products, such as a SaMD or digital diagnostic tools, we have extensive knowledge of the governing laws and regulations and broad-based practical experience with their application in advising clients to achieve competitive advantage by guiding on significant events that could adversely affect product quality, submission approval, compliance status, or pose a significant business risk. Our services cover: - Medical Device Cybersecurity Management - end-to-end consulting and creation of submission package (510(k), PMA) and addressing any Additional Information (AI) requests pertaining to the filing itself. - Medical Device Cybersecurity Threat Modeling, SBOM analysis and generation, Vulnerability Assessment and Penetration Testing, Continuous Threat Monitoring, Supply Chain Risk Management (SCRM), and Cybersecurity Engineering. - SaMD, SiMD development, regulatory guidance, and filing, - Privacy & Data Governance (HIPAA, GDPR, CCPA) - Computer System Validation - GxP Data Integrity - GxP Regulatory Intelligence & Compliance - vCISO Security Consulting - On-going evaluation of existing corporate security posture, IT architecture, investment strategies, and compliance documentation. Cyber Security roadmap, medical device architecture, and addresses advanced Cyber Security Challenges such as insider threats, Cyber SCRM, and fraud detection. This service covers both corporate and individual devices/systems.
- 网站
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https://www.cyberacta.com
CyberActa的外部链接
- 所属行业
- 科技、信息和网络
- 规模
- 2-10 人
- 总部
- Boston ，Massachusetts
- 类型
- 私人持股
- 创立
- 2020
- 领域
- cybersecurity、privacybydesign、compliance、GDPR、CCPA、medicaldevicecybersecurity、SaMD、Regulatory Strategy 、QMS、medical device software、Data integrity、Real-World Data、Design Control、De Novo、ISO 14971、ISO 13485、Software Bill of Materials (SBOM)、Threat modeling、GRC、FDA、EMA、IMDRF、EU MDR和EU IVDR
地点
CyberActa员工
动态
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Learn more about EasyCLIN?, an advanced clinical trial management software (#CTMS) suite equipped with a built-in #database, providing clients with a streamlined pathway to ensuring the efficiency, #compliance, and security of their #clinical trials. The EasyCLIN? suite affords #pharmaceutical, #biologics and #medicaldevice clinical trial #sponsors a central collaboration platform for all sites and parties involved in a multi-centric trial, effective facilitation of clinical #product development in compliance with EU #GDPR, 21 CFR Part 11, #ICH GCP E6 and enhanced value for regulatory and quality documentation. #FDA #EMA
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CyberActa转发了
We are proud to have been honoured with the Corporate Excellence Award by the AI Global Media Group as ‘Best Clinical Trial & Medical Research Software Solutions Company 2024 - Europe’. Corporate Vision Magazine AI Global Media IDS-Group (Interactive Digital Systems) Veridat CyberActa Swiss Tech Capital AG https://lnkd.in/eFxu84uc
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CyberActa转发了
A well-crafted incident management strategy is essential to protect operations and ensure resilience. John Giantsidis of CyberActa offers valuable insights on building an effective cybersecurity incident response plan, sharing key considerations and a proven framework to safeguard your organization. #Pharma #Biotech #SmartManufacturing #CyberSecurity #DigitalTransformation #AI #SupplyChain
Life Sciences Cybersecurity Incident Management: The End-to-End Approach
cellandgene.com
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CyberActa转发了
Exciting News! We're thrilled to announce that CyberActa, a Massachusetts-based leader in developing, validating, marketing and distribution of cutting-edge IT solutions in medicine, security, and compliance, has officially taken over representation of SynapCon in North America. This strategic partnership, combined with Veridat, an Ohio-based pioneer in distributed ledger technology, will elevate SynapCon's systems to new heights, ensuring top-tier performance and competitiveness for years to come. We're excited about the opportunities this collaboration brings and look forward to driving innovation together! #Innovation #HealthcareTechnology #Cybersecurity #Compliance #Partnerships #Blockchain #DistributedLedger #SynapCon #CyberActa #Veridat John Giantsidis Holger Bengs Holger Fuhrmann Ludwig Lutter Marcus Orton For inquiries and presentations, please reach out to: North America: Maria Papademetris Business Development, SynapCon Portfolio CyberActa, Inc. ?? +1 617-830-3041 ?? [email protected] Europe: Sven Engel SynapCon GmbH ?? [email protected]
Revolutionizing Clinical Trials with EasyCLIN?
einpresswire.com
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CyberActa转发了
Experienced Clinical GCP auditor (Internal, ISA, PV, TMF, and Vendor) with experience in quality management role (R&D, Clinical Quality, Quality Compliance) in support of clinical trials.
I’ve been part of several conversations about AI in clinical trials over the past week. Take a look John Giantsidis summary.
Pharmaceutical and biologics adoption of #artificialintelligence just received another #regulatory boost. European Medicines Agency spells out that any such adoption shall meet EU #AIACT, data protection?(including #GDPR), #cybersecurity (including the #CRA), and #NIS2. It is advisable for any AI/ML use case, whether submitted to #FDA or #EMA, would need to have evidence of: ? Human oversight ? Technical robustness, security and safety ? Privacy and data governance ? Transparency ? Accountability ? Societal and environmental well-being ? Diversity and fairness. Veridat, CyberActa, SynapCon - Faster Clinical Trials (SaaS) AI & ML-based platform for Medtech, Biotech and Pharma are here from drug discovery and?development to pharmacovigilance and clinical studies. ?? https://lnkd.in/eY3DgFg9 for more details.
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CyberActa转发了
Our own F. Scott Hall is joining top leaders in the country to chart the course of AI progress, and the critical steps to ensure the health and wellbeing of all Americans. The #NIRMH2024 covers accessibility, governance, policy, law, health equity, and actionable insights from thought-provoking panels and keynote sessions. Learn more and Register ? https://lnkd.in/eG9ngYfU. #AI #ArtificialIntelligence #Health #HealthCare?#governance #law #regulatorycompliance #policy
TRI-STATE SYMPOSIUM | National Institute O
nirmh.us
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CyberActa转发了
I'll be giving a talk at the National Institute of Rural & Minority Health Tri-State Symposium later this month, explaining all the potential potholes on the highway to using AI in an equitable way. Hope to see you there!
Explore the intersection of law, ethics, and patient representation at the Tri-State Symposium's DEI AI & Law, and Ethics continuing education panel. 6/20 5:00 p.m. F. Scott Hall, PhD, BA, Managing Partner, Veridat, Professor of Pharmacology & Experimental Therapeutics at University of Toledo Scot MacTaggart, Chief Innovation Officer, Dagostino Electronic Services, Entrepreneurial Mentor, Ascender Pittsburgh Member, Advisory Board, Ignite Business Incubator at Washington & Jefferson College To learn more about their sessions & purchase tickets, click here. https://lnkd.in/eG9ngYfU #HealthLaw #HealthEquity #HeathcareEthics #MinorityHealth #HealthCare #HealthcareLaw
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