firm-medtech-pack
Installation
SKILL.md
firm-medtech-pack
Sector bundle for medical technology & digital health environments.
Activated departments
| Department | Services activated | Focus |
|---|---|---|
| RA | Regulatory Affairs · Compliance Legal | FDA 510(k), CE Marking, MDR |
| Research Development | Research Discovery · R&D Prototyping | Clinical evidence, biomarker research |
| Quality | Compliance Auditing · Reliability · Security | ISO 13485, IEC 62304 |
| Legal | Privacy/Data Protection · IP | HIPAA, patient data, patents |
| Operations | Documentation · SRE/Incident | DHF, adverse event reporting |