Right Solution, on time.
Quality systems,
engineered
for medical devices.
QUALITY MANAGEMANT
ISO
13485:2016
US COMPLIANCE
21 CFR Part
820
EU COMPLIANCE
EU MDR
745/2017
RISK MANAGEMENT
ISO
14971:2019
MDSAP
AUDIT APPROACH
OUR CORE COMPETENCY
From pre-submission strategy to post-market surveillance, we will work with your team to deliver compliance that accelerates your roadmap.
Build ISO 13485 and 21 CFR 820 compliant quality systems from the ground up lean, practical, and audit ready.
QMS Implementation
ISO 14971 aligned hazard analysis, FMEA facilitation, and benefit risk determination across the lifecycle.
Risk Management
510(k), De Novo, PMA and CE technical files. Strategy, authoring, and agency correspondence end- to- end.
Regulatory Submissions
Internal audits, mock FDA inspections, gap assessments, and CAPA programs that actually close findings.
Audit & Remediation
Design Controls
Create, update, and leverage Design History Files that hold up under regulatory scrutiny.
Training & Advisory
Fractional QA/RA leadership and team training from design engineers to board level strategy
Our Approach
“Rigor, without the red tape.”
Every engagement begins the same way: listen carefully, assess honestly, and commit to a plan that respects your runway. Our custom approach ensures compliance without system bloat.
01
Discovery
A confidential intake call to understand your device, market, and regulatory posture.
02
Gap Assessment
We map your current state against applicable standards and identify the critical path.
03
A fixed-scope proposal with milestones, deliverables, and a formal statement of work (SOW).
Engagement Plan
04
Execution
Embedded, hands-on work — procedures, submissions, audits — alongside your team.