“Make everything as simple as possible, but not simpler.” – Albert Einstein
At Lean RAQA Systems, 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.
With constant change, navigating the complex regulatory environment can feel more like being lost in a maze. Lean RAQA Systems will find the most direct path for your project objectives, saving you time and money by expediting product commercialization and compliance.
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 more efficiently review and clear your product for the market.
Quality Systems and Compliance
Once your product receives clearance, the real work of maintaining a compliant quality system begins! Lean RAQA Systems 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 easily maintain compliance with minimal resources.
Make Quality Make Sense™
There are three key factors needed to Make Quality Make Sense™ throughout a medical device 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 Systems offers diagnostics, coaching tools, and consulting services to assess organizational needs for your medical device company to maximize the value in quality and patient safety.
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 Systems supports the due diligence process with strategic regulatory assessments reducing unknowns by exposing possible challenges that will impede product commercialization or require costly remediation efforts.
No matter what area you need support for – risk management, usability, requirements management, engineering protocols and reports, test plans, rationales, justifications – Lean RAQA Systems can provide resources to ensure project success.