Insights Techkrates
Insights
Practical, engineering-first notes for MedTech teams, focused on evidence, scope, and execution. Written by Filip Jaromczyk.
- Windows CE to Windows 10 IoT (IEC 62304): migration checklist Senior-engineer playbook with scope boundaries, evidence checklist, and cybersecurity workstream. Read the article
- Omron D6F airflow safety system: root causes and fixes Why production installs failed: turbulence, placement bias, scaling, and redundancy logic. Read the article
- IQ vs OQ in practice: What evidence counts (and what does not) How to keep installation and operational evidence clean, traceable, and audit-ready. Read the article
- FAT vs SAT: Acceptance criteria that prevent surprises Define measurable criteria and use a punch-list workflow that closes gaps before qualification. Read the article
- CSA explained for MedTech: Fewer tests, not less safety Risk-based assurance that reduces low-value testing without reducing evidence quality. Read the article
- Qualification documentation gaps that delay equipment release Common gaps in drawings, specs, and work instructions, and how to close them fast. Read the article
- CSV/CSA for connected HW/SW systems: Scope, traceability, test strategy Practical boundaries and evidence planning for connected devices, cloud, and mobile apps. Read the article
- Designing test stands for repeatability: GR&R and MSA Engineering choices that make test data trustworthy in real projects. Read the article
Articles in Polish: PL Insights
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