About Us
Eric Klumper
Kelsey Lee
Consulting
QMS Implementation & Project Management
510(k) & CE Mark Submission Consulting | Medical Device Regulatory Strategy
IEC 60601-1 Certification Consulting
Regulatory and QMS Consulting
Medical Device QMS Audit
Contact Us
Blog
White Paper: Applying Sandy Munro’s Methodology
Capabilities
Early Concept Design & Feasibility
Project Development & Precision Manufacturing
Comprehensive Regulatory Strategy
Supply Chain & Logistics
About Us
Eric Klumper
Kelsey Lee
Consulting
QMS Implementation & Project Management
510(k) & CE Mark Submission Consulting | Medical Device Regulatory Strategy
IEC 60601-1 Certification Consulting
Regulatory and QMS Consulting
Medical Device QMS Audit
Contact Us
Blog
White Paper: Applying Sandy Munro’s Methodology
Capabilities
Early Concept Design & Feasibility
Project Development & Precision Manufacturing
Comprehensive Regulatory Strategy
Supply Chain & Logistics
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Dec 27, 2025
Comprehensive Regulatory Strategy
Dec 27, 2025
Early Concept Design & Feasibility
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Our approach is straightforward— We engineer bold, defensible regulatory strategies that push your device through the FDA and into the field.
About Us
Eric Klumper
Kelsey Lee
Consulting
QMS Implementation & Project Management
510(k) & CE Mark Submission Consulting | Medical Device Regulatory Strategy
IEC 60601-1 Certification Consulting
Regulatory and QMS Consulting
Medical Device QMS Audit
Contact Us
Blog
White Paper: Applying Sandy Munro’s Methodology
Capabilities
Early Concept Design & Feasibility
Project Development & Precision Manufacturing
Comprehensive Regulatory Strategy
Supply Chain & Logistics
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