leanRAQA

At Lean RAQA, our mission is to deliver medical device Regulatory and Quality system solutions customized to your business needs. Regulatory strategy, quality systems, and submissions are not one size fits all. Clients get practical, sustainable solutions that meet their business needs without creating undue burden.

Regulatory Strategy
With constant change, navigating the complex regulatory environment can feel more like being 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. By Making Quality Make Sense™, a company realizes value and then Quality Makes $ense™. 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.

Technical Support
No matter what area you need support for – risk management, usability, engineering protocols and reports, test plans, rationales – Lean RAQA can provide resources to ensure project success.

Company’s Keywords:

510, technical file, due diligence, quality systems, regulatory intelligence, regulatory strategy, compliance, risk management, usability