China's Best One-Stop Medical Equipment Provider
About

leanRAQA is a consulting company focused on regulatory affairs and quality assurance, founded in 2010 by Michelle Lott. The firm serves startups and small to mid-sized businesses in regulated industries such as medical devices, dietary supplements, biologics, pharmaceuticals, cosmetics, and food. Operating virtually from Arizona, leanRAQA provides services across the United States and globally. The company specializes in developing regulatory strategies, preparing clients for audits, remediating compliance issues, and maintaining quality systems. Their core offerings include regulatory affairs consulting, quality assurance services, audit preparation, and technical support for regulatory submissions. Additionally, leanRAQA has created tools like the Business Market Assessment Tool, which helps companies assess the costs associated with regulatory compliance and evaluate market viability. This is particularly beneficial for smaller companies with limited budgets. Overall, leanRAQA is dedicated to helping clients navigate complex regulatory landscapes efficiently and cost-effectively.

Technologies
Rackspace MailGun SMTP.com Gmail Google Apps Wistia Mobile Friendly Google Tag Manager reCAPTCHA Drip Shutterstock Gravity Forms Nginx Bootstrap Framework WordPress.org Google Font API Sisense KNIME Remote Domo
Keywords
510 technical file due diligence quality systems regulatory intelligence regulatory strategy compliance risk management usability unique device identification medical equipment manufacturing services quality assurance regulatory submissions 510(k) submissions regulatory pathway guides fda compliance regulatory compliance medical device risk mitigation regulatory support healthcare regulatory due diligence regulatory audit prep other scientific and technical consulting services regulatory grief counseling product registration medical devices eu mdr iso 13485 b2b
Company Information
  • Employees 7
  • Founded 2011
Location

131 E Loch Lomond Pl, Oro Valley, Arizona, United States, 85737-9765

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