OptimaGRC is an AI-powered integrated GRC platform. It unifies governance, risk, and compliance across fifteen modules: Compliance Management, Risk Management, Audit Suite, Incident Management, Business Continuity Suite, People, Trust, Vendor & Third Party Risk, Policy & Document Management, Asset Management, Quality Management, Health, Safety & Environment (HSE), Data Governance (including DPIA), DMS, and Regulatory. Unlimited custom dashboards and KPIs (including Jawda packs) sit on the GRC spine. OptimaTrust is a separate AI Assurance product that can integrate with OptimaGRC.

What is OptimaTrust — is it part of OptimaGRC?

No. OptimaTrust (https://trust.optima360.io) is a full AI Assurance platform in its own right: verify, validate, monitor, and assure AI systems for explainability, bias and fairness, and compliance-ready evidence. It is not a built-in OptimaGRC module. When both are in use, OptimaTrust integrates with OptimaGRC so AI risk and model evidence inform governance, risk, Data Governance (including DPIA), and audit.

Is OptimaGRC only for information security and ISO 27001?

No. Information security (ISO 27001, SOC 2, NIST, PCI DSS) is fully supported, but OptimaGRC is also built for ISO 9001 Quality, ISO 45001 / 14001 HSE, ISO 22301 Continuity, ISO 31000 enterprise risk, GDPR and UAE PDPL Privacy, DORA and SAMA financial resilience, UAE NESA, Saudi NCA ECC, healthcare standards such as HIPAA and ADHICS, and 140+ other libraries. It is an operational GRC platform, not a security-only checklist tool.

Is OptimaGRC available as SaaS and On-Premise?

Yes. Standard and Professional are SaaS-only. Enterprise is available in dedicated SaaS and sovereign On-Premise. Packages are Standard, Professional, and Enterprise. See https://optimagrc.com/editions. Request a working session at https://optimagrc.com/contact.

Which GRC modules does OptimaGRC include?

Fifteen integrated modules: Compliance Management, Risk Management, Audit Suite, Incident Management, Business Continuity Suite, People, Trust, Vendor & Third Party Risk, Policy & Document Management, Asset Management, Quality Management, HSE, Data Governance (including DPIA), DMS, and Regulatory — plus unlimited custom dashboards.

What is the DMS module?

DMS is OptimaGRC’s document factory. It generates policies, procedures, forms, and work instructions from 200+ catalogues, applies the organisation template, and issues unique document reference numbers. Issued documents then follow lifecycle, attestation, and the evidence vault in Policy & Document Management. Details: https://optimagrc.com/modules/dms

What is the Regulatory module?

Regulatory governs legal and regulatory documents (laws, licences, circulars, permits), ships industry-vertical regulatory KPI packs, and includes a custom KPI builder. Metrics pin to unlimited dashboards and share only to a registered user email. Details: https://optimagrc.com/modules/regulatory and https://optimagrc.com/kpis

How many regulatory frameworks does OptimaGRC support?

OptimaGRC supports 140+ frameworks and control libraries, including ISO, NIST, SOC 2, GDPR, HIPAA, FedRAMP, COBIT, ITIL, PCI DSS, UAE NESA/IAS, UAE PDPL, SAMA, NCA ECC, DORA, NIS 2, ISO 9001, ISO 14001, ISO 45001, and more. Controls can be mapped once and inherited across overlapping obligations.

How does AI work in OptimaGRC?

The AI layer is designed to predict, analyze, assure, and automate. It drafts policies, maps controls across frameworks, detects regulatory and evidence drift, clusters incidents, pre-fills vendor and customer questionnaires from live evidence, and recommends risk treatments. Humans remain in approval workflows.

Who is OptimaGRC for?

CISOs, CROs, compliance officers, Quality managers, HSE leaders, internal audit, COOs, and boards in manufacturing, healthcare, BFSI, IT, energy, pharma, public sector, education, and retail. It is equally relevant to enterprises running an ISMS and to operators running integrated QMS/OH&S/EMS programs.

Does OptimaGRC support UAE and GCC regulations?

Yes. Regional libraries include UAE PDPL, UAE NESA/IAS, ADHICS, Saudi NCA ECC, and SAMA CSF, alongside global ISO and industry standards. The product is operated with UAE go-to-market and data-residency options in mind.

Can OptimaGRC replace spreadsheets and siloed GRC tools?

Yes. OptimaGRC is intended as the system of record for obligations, risks, audits, incidents, documents, vendors, assets, and people attestations — replacing spreadsheet GRC and reducing the need for separate QMS, EHS, and cyber-GRC products.

Does OptimaGRC integrate with existing enterprise systems?

OptimaGRC is designed for 100+ integrations across ITSM, cloud, identity, collaboration, and business systems so evidence and asset data stay fresh. OptimaTrust (https://trust.optima360.io) is a full AI Assurance platform — not a module inside OptimaGRC — that integrates so explainability, bias and fairness, and model evidence can inform GRC risk, Data Governance, and audit.

How do I request a demo of OptimaGRC?

Request a demo at https://optimagrc.com/contact. An OptimaGRC specialist will follow up from the form you submit.

Does OptimaGRC include a regulatory KPI library?

Yes. The Regulatory module governs legal documents and industry-vertical KPI packs, and includes a custom KPI builder. Unlimited regulatory and custom KPIs, pre-built Jawda / UAE Government Excellence packs, Data Governance privacy metrics (including DPIA), and unlimited custom dashboards sit on the same spine. Preview at https://optimagrc.com/modules/regulatory, https://optimagrc.com/kpis, and https://optimagrc.com/dashboards.

How do I estimate ROI for OptimaGRC?

Use the working calculator at https://optimagrc.com/roi. It estimates annual audit-prep hours from headcount, discounts extra frameworks for control overlap, applies an 80% automation rate to evidence work, and computes net savings, ROI, and payback against the platform investment you enter.

ISO 13485 software & GRC mapping

QMS requirements for medical device organizations, emphasizing risk, traceability, and regulatory documentation.

Why teams run ISO 13485 on OptimaGRC

Life-sciences quality can share supplier, CAPA, and document control with enterprise GRC rather than a standalone eQMS island.

How OptimaGRC supports ISO 13485

Device and process documented information
Supplier quality linked to TPRM
Complaint and CAPA traceability

Related OptimaGRC modules

Audit Suite Vendor & Third Party Risk Quality Management

Search phrases this page is built to answer: ISO 13485 software, medical device QMS GRC. OptimaGRC is the GRC platform that maps ISO 13485 alongside Quality, HSE, Privacy, and other international frameworks rather than treating it as an isolated checklist.

ISO 13485 GRC software

Why teams run ISO 13485 on OptimaGRC

How OptimaGRC supports ISO 13485

Related OptimaGRC modules

See OptimaGRC map your frameworks in one working session.