When cybersecurity can determine your device’s approval, our MedTech experts can help get you there.
From development through commercialization, Peritia brings cybersecurity expertise that helps MedTech companies build safe, compliant, and trusted products. We help increase safe innovation and market position, while working to prevent costly recalls.
Cybersecurity Experts Who Understand MedTech
In connected healthcare, cybersecurity is patient safety. One vulnerability can alter device performance, expose data, and disrupt care. That’s why you need experts who understand how technology, regulation, and trust come together.
Peritia consultants have deep MedTech experience and certifications such as RAC, PMP, ASQ, and cybersecurity standards. We embed directly into your team, providing hands-on, flexible support to keep programs moving forward.
Expert Support Exactly When You Need It
Cybersecurity challenges can arise at any stage of product development—whether you’re designing your first connected device, preparing for an FDA submission, or responding to new global requirements.
Companies turn to Peritia when internal resources are stretched, deadlines are approaching, or expertise is missing in key areas like threat modeling, SBOM creation, or post-market security management.
Our flexible model means you get right-sized, right-time support that integrates seamlessly with your existing teams.
How We Help
1. Threat Modeling & Risk Assessment
TARA, SBOM analysis, and vulnerability reviews aligned with FDA and UL standards.
2. Secure Product & Architecture Design
Implement secure-by-design principles (access control, encryption, hardening, secure boot, logging). Review firmware/software architecture for cybersecurity gaps early in development.
3. Cybersecurity Documentation for Regulatory Submissions
Cybersecurity Plans, SBOMs, RTA checklists, and risk assessments for FDA submissions. Document threat models, security risk assessments, and patch/updates strategy.
4. Verification, Validation & Penetration Testing Coordination
Define security test plans, oversee penetration testing, and validate mitigations. Align V&V activities with FDA, IMDRF, and global post-market expectations.
5. Secure Update, Patch, & Release Management
Build processes for authenticated updates, patch delivery, version control, and vulnerability monitoring integrated into QMS. Support post-market surveillance, security advisories, and coordinated disclosure.
6. Quality System & Compliance Integration
Embed cybersecurity into design controls, DHF documentation, QMS processes, and supplier controls. Ensure readiness for FDA inspections and cybersecurity audits.
Proven Results
Clients achieve secure, compliant, and market ready products with reduced risk, greater confidence, and on time. Cybersecurity becomes embedded into design controls, documentation, and quality systems supporting smoother inspections, fewer disruptions, and more confident product launches.
About Peritia
At Peritia, we accelerate life sciences with strategic expertise and solutions, supporting the full product journey—from concept to commercialization. In a rapidly evolving world, we unite experts, innovative thinking, and deep industry insight to provide high-value advisory, strategic, and just-in-time operational support. Our tailored deliverables empower scientific potential, enabling those with whom we work to advance their programs and achieve impactful results.