Struggling with regulatory hurdles, quality requirements, product development, commercialization roadblocks? Well, stay calm and innovate on, because we've got a new service offering designed specifically for medtech innovators like you. Introducing 𝙡𝙚𝙖𝙣𝙍𝘼𝙌𝘼 𝙇𝙖𝙪𝙣𝙘𝙝, a consulting-as-a-service solution that combines expert advice with actionable tools to accelerate your path to market: https://lnkd.in/gEgAxbmh 𝙡𝙚𝙖𝙣𝙍𝘼𝙌𝘼 𝙇𝙖𝙪𝙣𝙘𝙝 will help you avoid costly mistakes and find the most efficient - and compliant! - path to market. This program give you direct access to a team with 300+ years of combined medical device experience who will help you avoid pitfalls, move efficiently, and launch with confidence. Take the stress out of launching a product and sign up for 𝙡𝙚𝙖𝙣𝙍𝘼𝙌𝘼 𝙇𝙖𝙪𝙣𝙘𝙝 today: https://lnkd.in/gEgAxbmh #medicaldevices #regulatoryaffairs #FDA #compliance #quality #qualitymanagement #medtech #biotech #submissions #startups
About us
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.
- Website
-
http://leanraqa.com
External link for leanRAQA
- Industry
- Medical Equipment Manufacturing
- Company size
- 2-10 employees
- Headquarters
- Oro Valley, Arizona
- Type
- Public Company
- Founded
- 2011
- Specialties
- 510(k), Technical File, Due Diligence, Quality Systems, Regulatory Intelligence, Regulatory Strategy, Compliance, Risk Management, Usability, and Unique Device Identification (UDI)
Locations
-
Primary
Get directions
131 E Loch Lomond
Oro Valley, Arizona 85737, US
Employees at leanRAQA
-
Trey Thorsen, MS, RAC
Regulatory Consultant
-
Laura Nygard
Regulatory Affairs and Quality Assurance Consultant for the Medical Device and Pharmaceutical Industry
-
Renae Franz
Principal at Acacia Consultants | General Manager at leanRAQA
-
Michelle Lott, RAC
Regulatory Strategy and Submissions | Compliance | Audit Preparation + Remediation | Quality Systems | Design Controls | Due Diligence | Lean…
Updates
-
Announcing our next online course - 𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗮𝗻𝗱 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗤𝗠𝗦𝗥! This course will launch April 1st and pre-registration is open: https://lnkd.in/ghZ-5GBa This course is designed to help both new and experienced regulatory professionals navigate the transition from the Quality System Regulation to the "new" Quality Management System Regulation. The sessions are brief and easy to digest while still giving you the information you need to be compliant by February 2, 2026. Claim your seat now: https://lnkd.in/ghZ-5GBa #medicaldevice #compliance #FDA #qualitymanagement #medtech #biotech #regulatoryaffairs #qmsr
-
-
But it's not Corrective and Preventative Actions, so..... #medicaldevices #regulatoryaffairs #compliance #quality #qualitymanagement #medtech #biotech
-
Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail? It's true. The road from medtech startup concept to commercialization is fraught with challenges. But with the right strategy and roadmap, achieving success becomes a clear, attainable goal. Check out this webinar presentation from last week on what you need to know to move your product from concept to commercialization with confidence. https://lnkd.in/dKi8_ErS #medicaldevices #regulatoryaffairs #compliance #quality #qualitymanagement #medtech #biotech
-
-
#medtech startups - we know the challenges you face. Regulatory hurdles, quality requirements, product development, commercialization—where do you even begin? Well, stay calm and innovate on, because we've got a new service offering designed specifically for medtech innovators like you who need top-tier expertise without the overhead of a full-time hire. Introducing 𝙡𝙚𝙖𝙣 𝙇𝙖𝙪𝙣𝙘𝙝𝙋𝙖𝙙, a consulting-as-a-service solution that combines expert advice with actionable tools to accelerate your path to market: https://lnkd.in/gEgAxbmh 𝙡𝙚𝙖𝙣 𝙇𝙖𝙪𝙣𝙘𝙝𝙋𝙖𝙙 will help you: - Avoid costly mistakes - Find the most efficient path to market - Launch confidently—on your terms 𝗧𝗵𝗲 𝗽𝗿𝗼𝗴𝗿𝗮𝗺 𝗶𝘀 𝘀𝘁𝗶𝗹𝗹 𝗶𝗻 𝗯𝗲𝘁𝗮, 𝘀𝗼 𝘄𝗲'𝗿𝗲 𝗼𝗳𝗳𝗲𝗿𝗶𝗻𝗴 𝗮𝗹𝗹 𝘆𝗼𝘂 𝗲𝗮𝗿𝗹𝘆 𝗮𝗱𝗼𝗽𝘁𝗲𝗿𝘀 𝗼𝘂𝘁 𝘁𝗵𝗲𝗿𝗲 𝟮𝟱% 𝗼𝗳𝗳 𝘆𝗼𝘂𝗿 𝗳𝗶𝗿𝘀𝘁 𝗺𝗼𝗻𝘁𝗵 𝘄𝗶𝘁𝗵 𝗮 𝟯 𝗺𝗼𝗻𝘁𝗵 𝗰𝗼𝗺𝗺𝗶𝘁𝗺𝗲𝗻𝘁. Get exclusive access to: - 2+ hours of monthly strategy and guidance - Regulatory guides, QMS frameworks & more - Monthly group Q&A with seasoned experts - Email support line for fast answers to your regulatory questions - And more! This program give you direct access to a team with 300+ years of combined medical device experience who will help you avoid pitfalls, move efficiently, and launch with confidence. Take the stress out of launching a product and sign up for 𝙡𝙚𝙖𝙣 𝙇𝙖𝙪𝙣𝙘𝙝𝙋𝙖𝙙 today: https://lnkd.in/gEgAxbmh Hope to see you there. #medicaldevices #regulatoryaffairs #FDA #compliance #quality #qualitymanagement #medtech #biotech #submissions #startups
-
-
Biocompatibility is a key component of FDA submissions, but too many end up derailed by incomplete or inaccurate testing plans. Don't put your product at risk. Register now for this FREE webinar event that will teach you all you need to know about the FDA's biocompatibility testing requirements: https://lnkd.in/gwkskZqH #FDA #medtech #biotech #510k #compliance #regulatoryaffairs #qualitymanagement #biocompatibility #medicaldevices
-
Introducing "𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁𝘂𝗽 𝗦𝗰𝗵𝗼𝗼𝗹: "𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗼𝗳 𝗙𝗗𝗔 𝗖𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲" Join expert Michelle Lott, RAC, founder of leanRAQA, for this FREE 4-week course. In collaboration with MedTech Leading Voice, this self-paced online course distills the best of Michelle’s recent webinars into twenty simple, 15-minute lessons with short videos and quizzes. Learn the critical steps to bring your device to the U.S. market faster. Don’t miss out on this 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 “𝗕𝗮𝗰𝗸-𝘁𝗼-𝗦𝗰𝗵𝗼𝗼𝗹” 𝗼𝗳𝗳𝗲𝗿: 𝗮 $𝟮𝟵𝟵 𝘃𝗮𝗹𝘂𝗲, 𝗻𝗼𝘄 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗳𝗼𝗿 𝗳𝗿𝗲𝗲 𝗳𝗼𝗿 𝗮 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗶𝗺𝗲: https://lnkd.in/gYY6a4Nu #medicaldevices #regulatoryaffairs #compliance #medtech #biotech #FDA #startup #510k #qualitymanagement
-
-
Are you clear on how QSMR, ISO 13485 and MDSAP overlap? Do you understand how they're different? Do you know what you need to do if complying with all three? Michelle answered all of these questions and more at the Medtech Canada MedTech Conference 2024: https://lnkd.in/gdQqyXt5 #medicaldevices #regulatoryaffairs #qualitymanagement #FDA #compliance #MDSAP #iso13485 #medtech #biotech
-
The MDR application deadline has come and gone, with more than 12,000 devices still without certification. The long-awaited QMSR has been released to mixed reviews. And artificial intelligence is rapidly advancing into every aspect of our lives - including healthcare. What does all this mean for you? Register for the next Medical Device Live Expert discussion, hosted by Monir El Azzouzi and featuring Rob Packard, Harsh Thakkar and leanRAQA's Michelle Lott, RAC: https://lnkd.in/gS_ius_H #medicaldevices #regulatoryaffairs #compliance #eumdr #FDA #qualitymanagement #medtech #biotech
𝐉𝐎𝐈𝐍 𝐔𝐒 𝐅𝐎𝐑 𝐓𝐇𝐄 𝐒𝐄𝐂𝐎𝐍𝐃 𝐌𝐃𝐋𝐄 𝐨𝐧 𝐉𝐮𝐥𝐲 19𝐭𝐡 This will be a great session to focus on the US market with: - How does the US see what happens in Europe with MDR - QMSR: What will this change? - Is registering AI devices in the US easy? My guests will be Michelle Lott, RAC Rob Packard Harsh Thakkar So register now and share that with your colleagues. You can comment or ask questions during the Live so don't miss it. #medicaldevice #regulatoryaffairs #MDLE #qualitymanagementsystem #FDA
Medical Device Live Expert #2: USA is in the place
www.linkedin.com
-
Be careful when choosing a third-party testing lab, and when you do, be sure to review all the data they send to you before submitting to the FDA. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA