Services

 

FDA Consulting, LLC can assist you with a wide range of domestic and international regulatory affairs and quality system requirements.

 

We maintain effective working relationships with managers and reviewers in multiple Divisions within the Center for Devices and Radiological Health (CDRH) in FDA.  

 

We partner with a number of industry experts on product-specific requirements, including product safety engineering to IEC standards, sterilization validation, biocompatibility testing, packaging validation, FDA and IEC laser safety regulations, and software validation.

 

Regulatory Submissions

 

  • FDA Establishment Registration and Listing
  • US Agent for Foreign Manufacturers
  • Investigational Device Exemptions (IDE)
  • Pre-Submission Meetings
  • 513(g) Request for Classification Information
  • Premarket Notification 510(k)
  • Premarket Approval Submissions (PMA)
  • Technical File/Design Dossier for CE Marking
  • Health Canada Licenses
  • Foreign country regulatory submissions

FDA and ISO Quality Systems Requirements

 

  • Design, implementation, and audit of quality management systems for conformity to 21 CFR Part 820 and ISO 13485  
  • Gap assessments and assistance in the preparation of quality system procedures 
  • Assistance with compliance with design and development planning requirements
  • Assistance with compliance with labeling requirements

 

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