home/categories/computational-chemistry/borghei-claude-skills-ra-qm-team-fda-consultant-specialist-skill-md
computational-chemistryresearch

fda-consultant-specialist

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

borghei
maintainer
borghei
اپ ڈیٹ ہوا 3/30/2026
اسٹارز
84
فورکس
21
quick start

Installation and usage

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

انسٹالیشن
$ install --globalskills.sh
استعمال

انسٹال کرنے کے بعد، آپ یہ اسکل ٹرمینل میں درج ذیل کمانڈ چلا کر استعمال کر سکتے ہیں:

skills use fda-consultant-specialist