Medical Device Risk Management
doesn't have to be difficult.
Just AskRiskie.
One platform for safety risk, cybersecurity, ecodesign, audits, supply chain, and M&A — with AI intelligence and state of the art analysis built in. Residual risk acceptability backed by FDA MAUDE, EUDAMED, and published evidence. No credit card required.
Full Professional access for 30 days · no credit card · no obligation
Everything covered. One platform.
Safety, AI and security risk converge. AskRiskie links every hazard, threat and AI failure mode in one register — so a security flaw that becomes a safety hazard, or an AI model that drifts, is one connected picture, not three disconnected files.
Safety & Performance Risk
ISO 14971:2019 hazard identification, risk evaluation, controls, and residual risk acceptability. AI-assisted hazard library with device-specific suggestions. Decisions backed by real-world evidence from FDA MAUDE, EUDAMED, PubMed, and ClinicalTrials.gov — not assertion. Included in every plan.
AI Risk
AI/ML failure modes — drift, bias, fairness, robustness — captured in the same register as safety hazards. Aligned with the emerging ISO 24971-2 guidance and BS/AAMI 34971:2023.
Security & Cybersecurity Risk
Integrated threat modelling linked directly to your safety risk management file. TARA-aligned assessments across IEC 81001-5-1, IEC 62443, NIS2, and FDA cybersecurity guidance.
Ecodesign & Environment
ISO 14006 / IEC 62430 aspect register, ESPR compliance, Digital Product Passport readiness, WEEE applicability, and GHG scope classification — pre-positioned for IEC 63686.
Supply Chain Risk
Supplier register, qualification tracking, component traceability, and risk profiling across quality, regulatory, financial, geopolitical, and continuity dimensions.
M&A Due Diligence
Rapidly assess acquisition targets against your regulatory and quality baseline. AI-powered gap analysis of uploaded technical files with structured findings export.
Everything you need, nothing you don't
Simple, transparent pricing
Start on safety. Switch on AI and security as your risk surface grows. 30-day free trial · no credit card.
Starter
Self-serve · small manufacturers. Get the core safety risk file right.
- Core: Safety & Performance Risk (ISO 14971)
- Up to 3 devices · 2 users
- Evidence engine (FDA MAUDE, EUDAMED, ClinicalTrials.gov)
- 21 CFR Part 11 / Annex 11 audit trail
- Audit-ready reports (PDF & DOCX)
- AI hazard suggestions
- 30-day free trial · no card required
Growth
Self-serve · scaling teams. Switch modules on as your risk surface grows.
- Everything in Starter
- Up to 15 devices · team collaboration
- 21 CFR Part 11 / Annex 11 audit trail
- Add modules at +€99/mo each:
- · Security (IEC 81001-5-1 / TARA)
- · Ecodesign (ESPR)
- · Supply chain risk
- Priority support
Enterprise
Multi-site manufacturers, acquirers, and consultant practices.
- All modules included
- Unlimited users & devices
- Multi-organisation / multi-site
- eQMS & system integrations (MasterControl, Veeva, Greenlight Guru)
- SSO / SAML · API access
- 21 CFR Part 11 / Annex 11 audit trail
- M&A due diligence (priced per engagement)
- Personalised report templates & branded outputs
- Custom regulatory frameworks & standards
- Dedicated customer success manager
- Consultant partner pricing & revenue share
- SLA & priority support
Are you a regulatory affairs or quality consultant?