REG-001
Regulatory Strategy
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Regulatory Affairs
Owner
Regulatory Affairs
ISO Clause
N/A
Category
Regulatory Submissions
Master regulatory strategy covering FDA 510(k) De Novo, EU MDR, ANVISA, and TGA pathways.
#regulatory-strategy#fda#eumdr#anvisa#tga
Regulatory Standards
21 CFR Part 820EU MDR 2017/745ANVISA RDC 665/2022TGAISO 13485:2016
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Regulatory Affairs | Initial release |