Resources
Engineering knowledge for medical device teams. Standards explained, methodologies unpacked, and the thinking behind how MANKAIND works.
Articles
What is an eQMS for medical devices?
What electronic quality management systems do, why medical device companies need one, and how a unified platform with PLM changes the game.
FundamentalsWhat is a Design History File (DHF) and why it should generate itself
The complete guide to DHF per 21 CFR 820.30—what it contains, why it's required, and how documentation can emerge from engineering work.
EngineeringHow engineering intelligence transforms FDA submissions
Design decisions flowing into submission-ready documentation. DHFs, 510(k), and PMA pathways—without the documentation tax.
EngineeringWhy PLM and eQMS should be one platform
The architectural case for unification—why siloed tools create documentation overhead and how a shared data model solves the cascade problem.
StandardsIEC 62304 for software as a medical device—what engineers need to know
Safety classes A through C, the software lifecycle, SOUP management, and V&V requirements for SaMD development.
StandardsMedical device regulatory frameworks—a complete guide for engineering teams
FDA, EU MDR, EU IVDR, IEC 62304, IEC 60601, ISO 14971, ISO 13485—what each requires and how they interrelate.
EngineeringDeveloping Class III medical devices—from design to PMA
The engineering journey for the highest-risk devices. Design controls at maximum rigor, the PMA pathway, and managing the cascade.
SecuritySecurity and trust for medical device development platforms
SOC 2 Type II, ISO 27001, ISO 42001, AES-256, zero retention—why each matters for your engineering IP.