Design Assurance Email Formats
Medical and Diagnostic Laboratories • 
Minneapolis-St. Paul, MINNESOTA, United States • 1-10 Employees
Key Contact at Design Assurance
Daniel Schaefer
Founder
Company overview
| Headquarters | Minneapolis-St. Paul, MINNESOTA, United States |
| Phone number | +17596178 |
| Website | |
| NAICS | 6215 |
| SIC | 641 |
| Keywords | Risk Management, Systems Engineering, Quality Assurance, Process Control, Pharmaceuticals, PMA, Wearables, Design And Development, Iso 13485, Iso 14971, Biologics, Iec 62304, 510K, Iec 60601-1, IVD, Point Of Care, Design Control, MDR, Quality Engineering, Implantables, Design Assurance, Iec 62366-1, Ivdr, Fda 21 Cfr 820, Fda 21 Cfr 211, Fda 21 Cfr 600, Iec 61010-1 |
| Founded | 2020 |
| Employees | 1-10 |
About Design Assurance
In the high-stakes world of medical devices, quality isn't just a feature; it's the foundation of patient safety and regulatory approval. Companies are struggling to navigate the labyrinth of FDA and international regulations, all while facing pressure to innovate and accelerate their time to market. A single design flaw or manufacturing defect can lead to devastating consequences: product recalls, costly legal battles, and a catastrophic loss of trust from both patients and providers. Our Quality Engineering consulting services provide a proactive, lifecycle-wide solution to these critical challenges. We don't just fix problems at the end of the process; we build quality and compliance directly into your device's DNA, from the initial R&D phase through to post-market surveillance. We partner with you to implement robust quality management systems compliant with ISO 13485 and seamlessly integrate risk management into every stage of your design and manufacturing process. Our expertise in areas like design controls, human factors engineering, and validation ensures your device not only meets but exceeds regulatory expectations for safety and efficacy. Ultimately, we help you move beyond a reactive, compliance-focused mindset to one of proactive excellence. By embedding quality engineering principles, we help you launch safer, more reliable devices faster, reduce the risk of costly post-market issues, and solidify your reputation as a trusted leader in medical innovation.
Employees by Management Level
Total employees: 1-10
Seniority
Employees
Employees by Department
Design Assurance has 1 employees across 1 departments.
Departments
Number of employees
Funding Data
Design Assurance has never raised funding before.
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