Safety and Regulatory




25+ years of Clinical Trial Experience

At Databean we advise on the best possible way to navigate through the regulatory process and arrive at FDA approval. Our team offers recommendations to make sure that your data is strong, best quality, and follows all rules and regulations.

We go beyond simply being knowledgeable about global regulations. As our team and company’s history proves, our global reach, expertise and experience are vast. We are an international group that strives to work with the most innovative biotech and medical device minds across the globe. Our international regulatory expertise helps facilitate our relationships with clients and influencers throughout the world and throughout our industry.

What We Do
  • Define Device Classification and Regulatory Pathways
  • Create Labeling and Intended Use Documentation
  • Perform End-to-end Evaluation of Design Processes
  • Develop a Regulatory Strategy and Negotiate with FDA and other Global Regulatory Bodies
  • Manage pre-market submissions including de novo, EFS, 510K, IDE and PMA applications in U.S. and Technical File/Design Dossiers for CE Mark
  • Safety coding and analysis (CEC/DSMB, Statistical Analysis)
  • Qualify vendors and perform QMS audits
  • Produce interim and final reports, including safety reports
 
How We Do It
  • Identify, assess impact, and strategize to mitigate risks
  • Leverage knowledge and experience with international standards and regulatory processes
  • Plan Strategic Regulatory Pathways including Device Classification, Risk Classification, Device Registration
 

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