Services & Pricing
Specialized solutions for Medical Device and HealthTech companies navigating AI security and regulatory compliance.
The AI Security Policy Pack for R&D
Secure your development process with enforceable policies and training for your engineering team.
What's Included:
- Custom AI/GenAI usage policy for your organization
- Engineering team training materials (slides + video)
- Implementation checklist and rollout guide
- Tool approval workflow template
- Incident response procedures
- Quarterly policy review framework
Ideal for: CTOs, VPs of Engineering, Development Team Leads
Outcome: Your team innovates safely with clear guardrails, protecting IP and PHI.
The MDR + AI Act Gap Assessment
Identify compliance gaps with a structured analysis against MDR/IVDR and EU AI Act requirements.
What's Included:
- Comprehensive gap analysis report
- Risk classification under EU AI Act
- Prioritized action plan with timelines
- Documentation requirements checklist
- Post-market surveillance strategy outline
- 2-hour consultation to review findings
Ideal for: Regulatory Affairs Managers, Quality Managers, Compliance Officers
Outcome: A clear roadmap to compliance, saving months of uncertainty and costly missteps.
The Notified Body Readiness Package
Streamline audit preparation with a pre-structured documentation suite and data room template.
What's Included:
- Pre-structured 'Data Room' template
- Technical file documentation templates
- Risk management file structure (ISO 14971)
- Software lifecycle documentation (IEC 62304)
- Cybersecurity documentation suite
- Traceability matrix templates
- Post-market surveillance plan template
- 4-hour audit preparation workshop
Ideal for: Founders, Quality Leads, Regulatory Teams preparing for certification
Outcome: Walk into your audit looking mature and prepared, significantly reducing time-to-certification.
Need a Custom Solution?
Every organization has unique challenges. We offer tailored consulting packages for complex compliance scenarios, ongoing advisory relationships, and enterprise-wide implementations.
Discuss Your Needs