Services

 

FDA Consulting, LLC can assist you with a wide range of US 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.

 

United States Domestic Regulatory and Quality Systems Compliance

 

  • FDA Establishment Registration and Listing
  • US Agent for Foreign Manufacturers
  • Investigational Device Exemptions (IDE)
  • Pre-Submission Meetings (Q-Sub)
  • 513(g) Request for Classification Information
  • Premarket Notification 510(k)
  • Premarket Approval Submissions (PMA)
  • 21 CFR Part 820 (QSR) Compliance 

International Regulatory and Quality Systems Compliance

 

  • European Union MDR/IVDR gap assessment
  • Preparation of technical documentation in STED format
  • Design, implementation, and audit of quality management systems for conformity to ISO 13485
  • Health Canada Licensure

 

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