AI in Healthcare Masterclass
Momentum is ISO 13485 certified for medical device software development. Every product we build follows quality management processes that meet ISO 13485 requirements, so your software is audit-ready from architecture through production.
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Our development processes follow ISO 13485 quality management. Design controls, risk management, traceability matrices, and documentation are produced as part of the workflow on every project, from the first sprint through delivery the same standards we apply across our HIPAA and GDPR engagements.
Validation, verification, and testing structured around ISO 13485 and IEC 62304 requirements. Our development lifecycle covers requirements traceability, design verification, system testing, and post-market surveillance activities from kickoff through release.
If your company is pursuing ISO 13485 certification, we provide gap analysis, documentation preparation, and audit readiness support. We went through the certification process ourselves, so we know what auditors look for and where most teams run into problems.
Infrastructure and code architecture structured for ISO 13485, FDA, MDR, and SOC 2 requirements. Traceability, version control, change management, and risk documentation built into the development workflow.
Schedule a strategy call to discuss your AI implementation for healthcare and get a detailed technical roadmap for your health app development project.
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ISO 13485 is the international standard for quality management systems in medical device development. It covers the full product lifecycle: design controls, risk management, supplier management, production, and post-market surveillance. For software companies, it means your development processes follow documented, auditable procedures that regulatory bodies recognize.
Yes. Momentum holds ISO 13485 certification for medical device software development. Our quality management system covers requirements gathering, design, development, testing, release, and maintenance. Every healthcare product we build follows these certified processes.
It means your software is built under a quality management system with design controls, risk management (per ISO 14971), traceability between requirements and test cases, documented change management, and validation protocols aligned with IEC 62304. In practice, this produces audit-ready documentation alongside your product, not as an afterthought.
ISO 13485 certification costs vary by company size and scope. Initial certification typically involves gap analysis, documentation development, internal audits, and the certification audit itself. The timeline ranges from 6 to 18 months depending on your current quality management maturity. When you work with Momentum, your product is already built under ISO 13485 processes, which reduces your own certification scope and timeline.
The process includes: establishing a quality management system, documenting procedures and work instructions, conducting internal audits, performing a management review, and passing an external certification audit by an accredited body. Maintaining certification requires annual surveillance audits and a full recertification audit every three years.
ISO 13485 certification is recognized by both the FDA (US) and under the Medical Device Regulation (EU MDR) as evidence of a quality management system. While ISO 13485 alone does not guarantee FDA clearance or CE marking, it provides the quality management foundation that both regulatory pathways require. Momentum builds products that meet ISO 13485 quality standards, which supports your FDA 510(k), De Novo, or MDR submissions.
Yes. Beyond building products under our own certification, we help healthcare companies prepare for their own ISO 13485 certification. This includes gap analysis against the standard, documentation development, internal audit support, and audit readiness review. We bring firsthand experience from maintaining our own certification.
Yes. Through our partnership with Vanta, we add continuous automated monitoring to our ISO 13485 quality management processes. Vanta verifies infrastructure controls, access policies, encryption status, and configuration compliance in real time. This supplements our certified QMS with automated evidence collection and control monitoring across approximately 50 regulatory frameworks, including HIPAA, GDPR, SOC 2, and ISO 27001.
