ViSU
ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control. ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction.
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Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.
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Threat Detective
Threat Detective is SBOM and vulnerability management software built for medical device teams.
Turn your SBOM and vulnerability analysis into submission-ready cybersecurity evidence, and keep that evidence current through post-market surveillance.
Threat Detective helps teams:
* Import CycloneDX and SPDX SBOMs
* Validate SBOM contents and required elements
* Identify vulnerabilities across multiple advisory sources
* Prioritise findings using CVSS, EPSS and CISA KEV
* Document exploitability, remediation and mitigation decisions
* Publish VEX
* Generate evidence for FDA, EU MDR and UK regulatory workflows
* Monitor every active device and software version for newly disclosed vulnerabilities
Purpose-built for medical device manufacturers, Threat Detective replaces spreadsheet-heavy vulnerability workflows with a structured, auditable process for premarket review and ongoing post-market surveillance.
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