Govern Risk. Build Trust. Demonstrate Compliance.
We help organisations manage risk, meet regulatory requirements, and implement effective governance systems for complex, high-risk technologies.
Risk management standards for medical device safety and compliance.
Direct senior principal engagement on regulatory strategy and audit.
Governance frameworks for high-risk algorithmic and software systems.
AI Governance
Frameworks for ethical, compliant, and transparent algorithmic systems.
Medical Compliance
Navigating EU MDR and global regulatory pathways for medical devices.
Risk Management
Evidence-driven safety assessments for high-consequence technologies.
Core Domains of Expertise
We provide expert consultancy for regulated industries, ensuring your technologies meet the highest standards of safety, quality, and trust.
Frameworks for EU AI Act compliance, risk management, and human oversight for complex algorithmic systems.
Strategic support for EU MDR compliance, technical documentation, and clinical evaluation pathways.
Evidence-driven risk assessment and mitigation strategies for high-risk and safety-critical technologies.
Implementation of robust QMS frameworks tailored to regulatory standards and operational efficiency.
Engineering usability into products to ensure safety, performance, and compliance with user-centric standards.
Comprehensive safety engineering and regulatory alignment for aerospace, defence, and automotive sectors.
Need support with governance, risk or regulatory compliance?
Our consultants are ready to assist with your specific project requirements.
Standards-Aligned & Evidence-Driven Approach
We bridge high-consequence compliance mandates with pragmatic engineering delivery. Our five-stage advisory process operationalises complex regulatory requirements into structured, audit-ready deliverables.
Risk-Proportionate
Targeted to your device classification, risk tier, and intended clinical or commercial use.
Evidence-Driven
Every governance policy and engineering control maps directly to verifiable documentation.
Integrated Standards
Unified risk files that simultaneously satisfy healthcare regulations and European AI mandates.
Phased Process Architecture
Select any phase to view procedural scope, key deliverables, and governing standard references.
Procedural Scope
We determine system classification across applicable directives, establish whether algorithmic systems qualify as high-risk, evaluate conformity dependencies, and benchmark existing technical documentation against notified body expectations.
Core Deliverables
Regulatory Boundary Matrix, Gap Audit Report, Harmonised Standards Roadmap
We review existing technical documentation and benchmark against EU MDR and EU AI Act requirements.
Govern Risk. Build Trust. Demonstrate Compliance.
We help organizations manage risk, meet regulatory requirements, and implement effective governance systems for complex, safety-critical technologies.
Key Metric
Regulatory Alignment
Core Deliverables
- AI Governance Readiness Assessments
- EU AI Act Compliance Audits
- AI Risk Management Frameworks
Key Metric
Submission Success
Core Deliverables
- EU MDR Technical Documentation
- Clinical Evaluation Strategy
- Post-Market Surveillance Systems
Key Metric
Standard Compliance
Core Deliverables
- Risk Management File Development
- Residual Risk Benefit Analysis
- Safety-Critical Hazard Analysis
Key Metric
Use-Error Incidents
Core Deliverables
- Usability Engineering File Setup
- Formative & Summative Testing
- User Interface Risk Mitigation
Need support with governance, risk or regulatory compliance?
We provide practical, evidence-driven guidance tailored to your specific industry and technology stack.
Professional Toolkits
Ready-to-implement templates and frameworks for regulatory compliance, risk management, and governance.
AI Governance Toolkit
Essential templates for establishing AI governance readiness and internal oversight.
Includes:
- AI governance policy template
- Human oversight procedure
- AI risk assessment matrix
- Supplier assessment checklist
- Governance framework guide
EU AI Act Compliance
Comprehensive documentation suite for aligning systems with EU AI Act requirements.
Includes:
- Conformity assessment template
- High-risk AI system register
- Technical documentation guide
- Transparency reporting forms
- Post-market monitoring plan
Medical Device Risk
Structured risk management templates aligned with ISO 14971 for medical devices.
Includes:
- Risk management plan template
- Hazard analysis worksheets
- Risk evaluation matrix
- Benefit-risk analysis form
- Residual risk summary report
QMS & Regulatory Pack
Complete QMS documentation set for medical device regulatory compliance.
Includes:
- Quality manual template
- Document control procedures
- CAPA management forms
- Management review templates
- Internal audit checklists
Need a custom compliance solution or library access? Contact our team to discuss your requirements.
Engineered assurance for high-risk industries.
Parker Risk & Governance provides specialist consultancy for regulated sectors. We bridge the gap between complex regulatory compliance and agile product delivery, ensuring safety and trust in medical devices, AI, and critical infrastructure.
Evidence-Driven Analysis
We replace generic advice with rigorous, data-backed assessments aligned with international standards and regulatory requirements.
Risk-Based Governance
We build resilient frameworks that manage complex technical risks while ensuring compliance with evolving global regulations.
Specialist Collaboration
We work as an extension of your team, providing deep expertise in medical devices, AI governance, and safety-critical systems.
Need support with governance, risk or regulatory compliance?
Book a consultation to discuss your specific regulatory needs and governance framework requirements.