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 & performance risk, cybersecurity, ecodesign, audits, supply chain, and M&A due diligence — all sharing the same device register, supplier data, and audit history. No silos, no spreadsheets.
Safety & Performance Risk
ISO 14971:2019 hazard identification, risk evaluation, controls, and residual risk acceptability. AI-assisted hazard library with device-specific suggestions. State of the art analysis drawing on FDA MAUDE, EUDAMED, PubMed, and ClinicalTrials.gov — so your residual risk acceptability decisions are backed by real-world evidence, not assertion.
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.
Audit Management
Plan and execute external audits with live finding capture, AI document analysis, and global intelligence from FDA, EUDAMED, PubMed, and ClinicalTrials.gov.
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 free. Upgrade when you need more.
30-Day Trial
Full Professional access — no credit card required.
- Up to 2 devices
- Safety & performance risk (ISO 14971)
- Cybersecurity risk (IEC 81001-5-1)
- Ecodesign & environment (ESPR / ISO 14006)
- Audit management & supply chain risk
- AI hazard suggestions & report generation
- –Full access expires after 30 days
Professional
Everything you need for a serious QMS. Billed annually or monthly.
- Unlimited devices
- Safety & performance risk (ISO 14971)
- Cybersecurity risk (IEC 81001-5-1)
- Ecodesign & environment (ESPR / ISO 14006)
- Audit management (ISO 13485 / EU MDR / FDA)
- Supply chain risk register
- M&A due diligence
- AI hazard & threat suggestions
- PDF report generation
- Up to 5 users
Enterprise
For larger teams, multiple legal manufacturers, or consultant practices.
- Everything in Professional
- Unlimited users & devices
- Multi-organisation / multi-site support
- SSO / SAML
- eQMS integration (MasterControl, Veeva, Greenlight Guru, others)
- Personalised report templates & branded outputs
- API access for custom integrations
- 21 CFR Part 11 / Annex 11 audit trail
- Custom regulatory frameworks & standards
- Dedicated customer success manager
- Consultant partner pricing & revenue share
- SLA & priority support
Are you a regulatory affairs or quality consultant? Ask about our partner programme.
Request a Demo
Prefer a guided walkthrough? We'll personalise it to your device type and regulatory context.