Regulatory strategy, quality systems, and submissions are not one size fits all. Our clients get practical, sustainable solutions that meet their business needs without creating undue burden.
Regulatory Strategy
Navigating the complex, ever-changing regulatory environment can feel like you’re lost in a maze. Lean RAQA can find the most direct path for your project objectives, saving your company time and money by expediting product commercialization and compliance.
Regulatory Submissions
Lean RAQA Systems uses the same strategic perspective to craft test plans, rationales, and justifications used to prepare 510(k)’s and Technical Files. Submissions are structured in way to clearly demonstrate safety, efficacy, and compliance so regulators can more efficiently review and clear your product for the market.
Make Quality Make Sense™
There are three key factors needed to Make Quality Make Sense™ throughout a company: Leadership, Organization and Culture. When these ingredients are combined, the quality policy and core values of your company become real and living. Lean RAQA offers diagnostics and coaching tools to assess organizational needs for your company to maximize the value in quality.
Quality Systems and Compliance
Once your product receives clearance, the real work of maintaining a compliant quality system begins! Lean RAQA builds customized quality systems scaled for the size of your company, the activities you conduct, and the markets you serve. A scaled approach ensures your company can maintain compliance with minimal resources.
Regulatory Due Diligence and Product Pathway Assessments
With any new venture, risk and unknowns are inherent. In the medical product market, regulatory is a key element in a successful business strategy. Lean RAQA supports the due diligence process with strategic regulatory assessments reducing unknowns by exposing possible challenges that could impede product commercialization or require costly remediation efforts.
Company Details
- Employees
- 8
- Founded
- -
- Address
- 131 E Loch Lomond, Oro Valley,arizona 85737,united States
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- leanraqasystems.com
- Keywords
- 510(k), Technical File, Due Diligence, Quality Systems, Regulatory Intelligence, Regulatory Strategy, Compliance, Risk Management, Usability, Unique Device Identification (UDI).
- HQ
- Oro Valley, Arizona
Leanraqa Questions
Leanraqa's website is leanraqasystems.com
Leanraqa's LinkedIn profile is https://www.linkedin.com/company/lean-raqa-systems
Leanraqa has
8 employees.
View email and phone details for 8
employees at Leanraqa.
Leanraqa's industry is
Medical Equipment Manufacturing
Leanraqa's top competitors are
Xeridiem Medical Devices,
Medtech Leading Voice,
Johner Institute New Zealand Ltd.,
Zimmer Biomet,
Cognition Corporation,
Alcon,
Fda,
Westmed Inc,
Rqm+,
Eliquent Life Sciences.
Leanraqa's categories are Medical Equipment Manufacturing
Leanraqa's founding year is 2011
