Security that moves with your business.
From SOC 2 and ISO certifications to AI governance and SaMD regulatory readiness — Insular builds the programs that let you close deals, pass audits, and scale without friction.
Book a Free CallThe foundation every SaaS company needs.
Credible security leadership, certification programs, and enterprise deal support — delivered as a practical operating advantage, not a compliance checkbox.
vCISO & Fractional CISO
A long-term security partner embedded in your team — not a one-time consultant. Insular brings CISO-level expertise at a fraction of the cost, giving your business credible security leadership at every stage of growth.
- Security program design & oversight
- Board & investor reporting
- Vendor questionnaire completion
- Audit leadership
- Ongoing security program management
Compliance Certification Programs
SOC 2, ISO 27001, and ISO 42001 certification programs — end-to-end. We handle the complexity so your team can stay focused on building.
- SOC 2 Type I & Type II readiness and audit support
- ISO 27001 Information Security Management System
- ISO 42001 AI Management System
- HIPAA & PIPEDA privacy compliance
- Gap analysis, policy templates, and evidence collection
Enterprise Sales Support
Complete vendor questionnaires, security reviews, and procurement assessments that keep your deals moving. Turn security from a blocker into a competitive advantage.
- Vendor security questionnaire completion
- Customer security review responses
- Procurement & due diligence support
- Security one-pagers and trust documentation
Built for companies shipping AI products.
AI introduces risks that standard security frameworks weren't designed for. Insular brings specialised governance, security architecture, and audit leadership for AI-native teams.
AI Governance Lead
Navigating AI governance requirements, data privacy, model documentation, and emerging regulatory frameworks — so your AI products can ship with confidence.
- ISO 42001 AI Management System implementation
- Model risk documentation & transparency reports
- Data governance and privacy-by-design
- Emerging AI regulation readiness (EU AI Act, NIST AI RMF)
AI Security Lead
Security architecture and threat modelling specifically designed for AI products, pipelines, and the unique risks they introduce.
- AI/ML threat modelling and attack surface analysis
- Training data security and supply chain risk
- Model access controls and inference security
- Adversarial input and prompt injection mitigations
Internal Audit Lead
Audit preparation and management — so you walk into every review confident, organised, and ready to pass.
- Pre-audit readiness assessments
- Evidence collection and organisation
- Auditor liaison and response management
- Remediation tracking and closure
Compliance-ready for FDA and Health Canada.
Software as a Medical Device carries regulatory obligations that go well beyond standard SaaS security. Insular helps healthtech companies build the documentation, controls, and quality systems that regulators expect — so you can bring your product to market with confidence.
SaMD Compliance Readiness
Software as a Medical Device (SaMD) carries regulatory obligations that go well beyond standard SaaS security. Insular helps healthtech companies build the documentation, controls, and quality management systems required to satisfy FDA and Health Canada reviewers.
- SaMD classification and regulatory pathway scoping (FDA, Health Canada)
- Quality Management System (QMS) design aligned to IEC 62304 and ISO 13485
- Software lifecycle documentation — SDS, SRS, risk management files
- Cybersecurity documentation per FDA Cybersecurity Guidance (2023) and Health Canada expectations
- Pre-submission meeting preparation and regulatory correspondence support
FDA & Health Canada Cybersecurity
Regulators now treat cybersecurity as a patient-safety issue. Insular prepares the security artefacts that FDA and Health Canada reviewers expect to see — and helps you maintain them through the product lifecycle.
- Cybersecurity risk management file (threat modelling, SBOM, vulnerability management)
- Security architecture documentation aligned to FDA Cybersecurity Guidance
- Post-market cybersecurity monitoring and patch management procedures
- Health Canada Medical Device Regulations cybersecurity alignment
- Incident response planning for regulated medical software
Not sure where to start?
Book a free 30-minute call. We'll identify the gaps that matter most for your business and map out a practical path forward.
Book a Free Call