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
CyberActa
Technology, Information and Internet
Boston , Massachusetts 273 followers
ENABLING DIGITALL™
About us
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.
- Website
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https://www.cyberacta.com
External link for CyberActa
- Industry
- Technology, Information and Internet
- Company size
- 2-10 employees
- Headquarters
- Boston , Massachusetts
- Type
- Privately Held
- Founded
- 2020
- Specialties
- 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, and EU IVDR
Locations
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Primary
Boston , Massachusetts , US
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Richmond, Virginia, US
Employees at CyberActa
Updates
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CyberActa reposted this
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 reposted this
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 reposted this
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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CyberActa reposted this
📢 Just published - new guidance for medical devices used in combination with medicines 💉 💊 🤝 The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. 🔍 What's inside: ➡ insights on integral drug-device combinations and their lifecycle management ➡ labelling requirements for medical devices co-packaged with medicinal products ➡ information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics Find out more: https://lnkd.in/d6wjy5KN #medicines #MedicalDevices #InVitroDiagnostics #CompanionDiagnostics
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CyberActa reposted this
Every company, #CEO, #CISO, #CLO and #GC ought to leverage this #SCOTUS ruling to reduce their legal & regulatory risks. CyberActa can take the helm on developing a practical, purpose-led risk governance playbook to help your company stay ahead. Veridat can enhance your #trust with varied stakeholders - investors, customers, employees, governments and regulators. Learn how on https://lnkd.in/eBnGzR2p.
US supreme court ruling suggests change in cybersecurity disclosure process
csoonline.com
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CyberActa reposted this
Data products have to designed, built, and maintained with the needs and requirements of its users in mind, just like a traditional product. By treating clinical data as a product, sponsors can stimulate a culture of data sharing and reuse under appropriate circumstances, which breaks down data silos and promotes cross-functional collaboration. This product orientation ensures that data is properly managed and governed, with clear accountability, quality, and access controls. Over time it will improve operational and analytical data quality, reduce data backlogs, lower data storage costs, and reduce data redundancy. These improvements will allow your organization to better leverage their data products and make more effective, data-driven decision-making. #data #transparency #clinical #sponsors #GCP Veridat
For the first time since 2006, the #FDA has proclaimed its broad expectations for the scope of oversight, conduct, and practices of a data monitoring committee (#DMC) in a new draft guidance. The public comment period ends April 15, 2024. https://lnkd.in/e9FGC4gU By John Giantsidis, president, CyberActa. and Remco Jan Geukes Foppen, Ph.D. #datamonitoring
New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials
clinicalleader.com
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CyberActa reposted this
Thrilled to announce that Veridat's Robert Huber has been invited to showcase our unimpeachable validation for use in heavily regulated industries, providing end-to-end visibility across networked operations, certifying provenance, supply- value and custody chains, establishing trust in Artificial Intelligence, and security for digital records, information and data. Innovation and trust begins at #LDNBlockchain24. See you in London Blockchain Conference! #trust #supplychain #provenance #ai #artificialintelliegnce #security #records #data #informationassurance #validation