SolutionsHealthcare & MedTech Regulatory Compliance
FDA 510(k), EU MDR & ISO 13485 Regulatory Architecture
Automate medical device classification & Notified Body dossiers.
Eliminate submission rejections and 6-month deficiency delays. Straits unifies risk management under ISO 14971, medical software safety under IEC 62304, and electrical safety under IEC 60601-1 into an audit-ready regulatory engine.
Regulatory Scope
FDA & EU MDR 2017/745
Class I, IIa, IIb & Class III
Harmonized Standards
ISO 13485 & ISO 14971
Bidirectional risk-to-test links
Submission Pass Rate
99.2% First-Round Pass
Zero major deficiency letters
Lead Persona
Sarah (QA & Reg Director)
MedTech Quality & Regulatory Affairs
Classification & Submission Engine
Interactive regulatory readiness checklist
Select your device classification and toggle completed verification artifacts to calculate your live Notified Body submission readiness gauge.
Regulatory Prerequisites for CLASS2
5 of 8 VerifiedLive Submission Readiness Score
63%In Progress
Target Agency:FDA 510(k) CDRH
Standard Set:FDA Special Controls
Quality Sign-off:21 CFR Part 11 Sealed
Persona Spotlight: Sarah
QA & Regulatory Affairs Director
“Straits replaced our 24 disconnected risk spreadsheets with a single visual tree. When Notified Body auditors ask for evidence on Clause 8.7.4, I click the node and instantly show the lab test artifact and digital signature.”
Accelerate your medical device clearance.
Book a dedicated consultation with Sarah and our medical device quality engineers to review your FDA 510(k) or EU MDR dossier roadmap.