Design Assurance™
You wouldn’t buy a house without an inspection. Why buy a medical device company without one?
We provide independent quality and regulatory inspections for investors, M&A teams, and buyers of medical device companies.
Design Control Services
-Design & Development Planning
-User Needs and Design Inputs
-System Architecture
-Subsystem Requirements
-Design Verification and Design Validation
-Sampling Plans and Sample Size Rationales
-Test Method Validation
Risk Management Services
-Risk Management Planning & Strategies
-Risk Assessments
-Post Market Risk Feedback
-Risk Management Review & Report
-Risk Control Identification and Effectiveness
Audit Services
-Internal & External Audits
-Design History Files (DHF) Assessments
-Risk Management Files (RMF) Assessments
-Device Master Records (DMR) Assessments
-Compliance / GAP Assessments
Quality System Services
-Document Mangagement Systems
-Policy and Procedures
-Design History Files (DHF)
-Risk Management Files (RMF)
-Device Master Records (DMR)
-Compliance to New Standards
-IVDR / MDR Compliance
-Audit Findings / Warning Letter Actions
-Muda (waste) Reduction
Process Control Services
-Master Validation Planning
-Process Mapping
-Control Planning
-Design Transfer
-Sampling Plans and Sample Size Rationales
-Quality Control (QC)
Other Services
-Acquisition Services
-Regulatory Services
-Remediation Services
-Post Market Surveillance Services
-Program/Project Management Services
-Clinical Trial Services
-CAPA Services
And many more. Just ask. We can do it all.
Contact Us
Please contact us below. We should respond within a few hours.
If you prefer to send direct email, please use info@designassurance.org.