LS
LSaiko
DOC LS-PORTFOLIO-01 REV C STATUS RELEASED
Engineering portfolio

Medical AI, built the way a
regulated device actually ships.

I design and validate deep-learning systems for clinical imaging, then build the FDA/ISO tooling — traceability matrices, audit trails, CAPA workflows — that gets them through design controls. QA automation and public-health data products round out the stack.

ACTIVE
Portfolio record
Prepared by
LSaiko
Disciplines
4
Repos under CM
31
Primary language
Python
Effective date
31
Repositories
11
Imaging models
9
Regulatory tools
5
QA frameworks
GitHub stars
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01Medical imaging, signals & deep learning

Classification, segmentation, and tracking across radiology, dermatology, endoscopy, cardiology, and surgery — each paired with explainability rather than a black-box score.

02Regulatory & quality engineering

Tooling that targets the standards real medical-device QMS teams answer to — 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 11 — turning compliance artifacts into generated, repeatable outputs.

03Public health & utilities

Live, source-attributed data products and NLP tooling — built to be free, transparent, and usable without an account.

04QA & test automation

Selenium and pytest frameworks covering UI, API, cross-browser, and database-integrity testing, each wired into a CI pipeline so every suite runs the same way on every push.

Four disciplines, one build process

The portfolio sits at an unusual intersection: the deep-learning skill to build clinical models, the regulatory fluency to push them through design controls, and the test-engineering discipline to keep all of it verifiably working.

SPEC 01 · IMAGING

Clinical imaging AI

Classification, segmentation, and tracking across radiology, dermatology, endoscopy, and surgery — consistently paired with explainability (Grad-CAM, bounding boxes, confidence scores) rather than black-box outputs.

SPEC 02 · REGULATORY

Regulatory & quality

Tooling that targets the standards real medical-device teams answer to: 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 11, AIAG MSA and AIAG-VDA pFMEA.

SPEC 03 · PUBLIC HEALTH

Data & public health

Live, source-attributed data products — most prominently a CDC-backed disease surveillance dashboard with AI summaries — built to be free and usable without an account.

SPEC 04 · QA

QA & test automation

Selenium/pytest frameworks covering UI, API, cross-browser, and database-integrity testing, with CI pipelines so every suite runs the same way on every push.