https://mankaind.ai/blog Engineering-first guides on medical device development, regulatory frameworks, eQMS, PLM, and design controls. Written by engineers, for engineers. en-us Thu, 16 Apr 2026 12:00:00 GMT https://mankaind.ai/blog/fda-agents-510k-review-2026 https://mankaind.ai/blog/fda-agents-510k-review-2026 Thu, 16 Apr 2026 12:00:00 GMT FDA deployed agentic AI agency-wide in Jan 2026 to review 510(k) submissions. What those agents look for — and how to write submissions for them. https://mankaind.ai/blog/eu-ai-act-medical-device-compliance-2026 https://mankaind.ai/blog/eu-ai-act-medical-device-compliance-2026 Wed, 15 Apr 2026 12:00:00 GMT EU AI Act enforcement begins August 2026. Dual conformity under EU MDR and the AI Act — what it requires, what you cannot defer. https://mankaind.ai/blog/fda-medical-device-cybersecurity-524b https://mankaind.ai/blog/fda-medical-device-cybersecurity-524b Mon, 13 Apr 2026 12:00:00 GMT FDA Section 524B requires cybersecurity submission data for every cyber device: SBOM, threat modeling, and post-market vulnerability management. https://mankaind.ai/blog/model-context-protocol-medical-device-integration https://mankaind.ai/blog/model-context-protocol-medical-device-integration Thu, 09 Apr 2026 12:00:00 GMT Model Context Protocol (MCP) lets one AI agent read your PLM, QMS, test management, and FDA database — with every access logged for audit. https://mankaind.ai/blog/rag-architecture-medical-device-documentation https://mankaind.ai/blog/rag-architecture-medical-device-documentation Wed, 08 Apr 2026 12:00:00 GMT RAG is winning in regulated industries. Citation-per-output makes it auditable by design. The architecture for medical device documentation. https://mankaind.ai/blog/reviewer-agent-pattern-regulated-ai https://mankaind.ai/blog/reviewer-agent-pattern-regulated-ai Mon, 06 Apr 2026 12:00:00 GMT The reviewer-agent pattern is the production answer to LLM hallucination in regulated AI — where domain-specific hallucination rates still run 15–23%. https://mankaind.ai/blog/context-engineering-medical-device-ai https://mankaind.ai/blog/context-engineering-medical-device-ai Thu, 02 Apr 2026 12:00:00 GMT Context engineering beats prompt engineering for regulated AI. Wrong standards, hallucinated predicates — these are context failures, not model failures. https://mankaind.ai/blog/predetermined-change-control-plan-fda https://mankaind.ai/blog/predetermined-change-control-plan-fda Wed, 01 Apr 2026 12:00:00 GMT FDA finalised PCCP guidance in Dec 2024. What a PCCP requires, how to write a defensible one, and how it connects to your risk file and DHF. https://mankaind.ai/blog/mdsap-medical-device-single-audit-program https://mankaind.ai/blog/mdsap-medical-device-single-audit-program Mon, 30 Mar 2026 12:00:00 GMT MDSAP combines FDA, Health Canada, TGA, ANVISA, and PMDA audits into one. Scope, grading, participation paths, and how ISO 13485 fits. https://mankaind.ai/blog/iec-62366-usability-engineering https://mankaind.ai/blog/iec-62366-usability-engineering Thu, 26 Mar 2026 12:00:00 GMT IEC 62366-1 usability engineering: formative vs summative evaluation, the UEF, hazard-related use scenarios, and the link to ISO 14971. https://mankaind.ai/blog/iec-60601-medical-electrical-equipment https://mankaind.ai/blog/iec-60601-medical-electrical-equipment Wed, 25 Mar 2026 12:00:00 GMT IEC 60601-1 governs medical electrical equipment safety. The general standard, collateral standards, particular standards, and essential performance. https://mankaind.ai/blog/iso-10993-biocompatibility-medical-devices https://mankaind.ai/blog/iso-10993-biocompatibility-medical-devices Mon, 23 Mar 2026 12:00:00 GMT ISO 10993 biocompatibility: contact categorization, ISO 10993-18 chemical characterization, and the test battery for medical devices. https://mankaind.ai/blog/ai-ml-risk-analysis-medical-device https://mankaind.ai/blog/ai-ml-risk-analysis-medical-device Thu, 19 Mar 2026 12:00:00 GMT Apply ISO 14971 to AI-enabled medical devices. Model drift, distribution shift, dataset bias, and hallucination — handled as failure modes. https://mankaind.ai/blog/soup-management-samd-iec-62304 https://mankaind.ai/blog/soup-management-samd-iec-62304 Wed, 18 Mar 2026 12:00:00 GMT SOUP management under IEC 62304: building an inventory, evaluating risk per item, handling version updates, and treating ML frameworks as SOUP. https://mankaind.ai/blog/medtech-cto-regulatory-playbook https://mankaind.ai/blog/medtech-cto-regulatory-playbook Mon, 16 Mar 2026 12:00:00 GMT A medtech CTO regulatory decision framework: what to decide in 30, 60, 90 days — and the three patterns that cost startups 12 months. https://mankaind.ai/blog/quality-system-medical-device-startup https://mankaind.ai/blog/quality-system-medical-device-startup Thu, 12 Mar 2026 12:00:00 GMT Three engineers, a regulatory consultant, and FDA expecting 200-person design controls. The minimum viable QMS for a pre-Series A medtech. https://mankaind.ai/blog/class-iii-medical-device-development https://mankaind.ai/blog/class-iii-medical-device-development Wed, 11 Mar 2026 12:00:00 GMT Class III devices follow the PMA pathway — the most rigorous in FDA regulation. Design controls rigor, full traceability, and V&V depth in practice. https://mankaind.ai/blog/regulatory-frameworks-medical-devices https://mankaind.ai/blog/regulatory-frameworks-medical-devices Mon, 09 Mar 2026 12:00:00 GMT FDA 21 CFR 820, 510(k), PMA, De Novo, EU MDR, EU IVDR, IEC 62304, IEC 60601, ISO 14971, ISO 13485 — how they interrelate for engineers. https://mankaind.ai/blog/iec-62304-samd-compliance https://mankaind.ai/blog/iec-62304-samd-compliance Thu, 05 Mar 2026 12:00:00 GMT IEC 62304 software lifecycle for SaMD teams: Class A, B, C safety classification, SOUP management, and the V&V documentation cascade. https://mankaind.ai/blog/ai-medical-device-requirements https://mankaind.ai/blog/ai-medical-device-requirements Wed, 04 Mar 2026 12:00:00 GMT An honest assessment of using AI for medical device requirements. What ChatGPT/Claude get right, what they miss, and what purpose-built AI changes. https://mankaind.ai/blog/graph-based-traceability-medical-device https://mankaind.ai/blog/graph-based-traceability-medical-device Mon, 02 Mar 2026 12:00:00 GMT Reframe medical device requirements traceability as a directed graph, not a spreadsheet. Why that changes development, not just documentation. https://mankaind.ai/blog/how-to-write-medical-device-requirements https://mankaind.ai/blog/how-to-write-medical-device-requirements Thu, 26 Feb 2026 12:00:00 GMT Write medical device requirements that pass FDA review. EARS notation, six quality attributes, and traceability from line one — a practical guide. https://mankaind.ai/blog/medical-device-data-security https://mankaind.ai/blog/medical-device-data-security Wed, 25 Feb 2026 12:00:00 GMT Engineering decisions are the most sensitive IP your company holds. SOC 2 Type II, ISO 27001, ISO 42001, AES-256, and zero data retention. https://mankaind.ai/blog/fda-compliance-automation https://mankaind.ai/blog/fda-compliance-automation Mon, 23 Feb 2026 12:00:00 GMT FDA submissions start in design decisions, not Word documents. How engineering intelligence generates submission-ready DHF documentation automatically. https://mankaind.ai/blog/plm-vs-eqms-medical-devices https://mankaind.ai/blog/plm-vs-eqms-medical-devices Thu, 19 Feb 2026 12:00:00 GMT PLM and eQMS have been separate for decades. That separation imposes a documentation burden and creates regulatory exposure. The case for unification. https://mankaind.ai/blog/what-is-design-history-file-dhf https://mankaind.ai/blog/what-is-design-history-file-dhf Wed, 18 Feb 2026 12:00:00 GMT A DHF is required by 21 CFR 820.30 and captures every design decision from input through validation. Why the DHF should generate itself. https://mankaind.ai/blog/what-is-eqms-medical-devices https://mankaind.ai/blog/what-is-eqms-medical-devices Mon, 16 Feb 2026 12:00:00 GMT An eQMS manages CAPAs, NCRs, complaints, audits, and document control. How a unified platform with PLM makes quality a natural output of engineering.