We specialize in regulatory & quality questions and submissions, as well as diagnosing and fixing quality problems.

We help manufacturers make timely and effective regulatory submissions and identify and remediate QMS issues.

We routinely assist clients with premarket submissions, regulatory notifications and filings. We also assist manufacturers with meeting Quality Management System obligations. We can perform mock audits and assess your QMS for compliance with various regulatory authorities including FDA Part 820, the EU MDR, MDSAP, ISO 13485:2016 QMS gap analysis. We also have non-legal staff that specialize in operations support who can assist with design transfer, production setup, and supply operations.

Contact us to get started.

FDA Regulatory Submissions and Quality Management System services include:

  • Regulatory opinions
  • Product approval pathway assessments
  • QMS administration, audits, remediation
  • CAPA process facilitation
  • 510(k)
  • Premarket Approval (PMA)
  • Pre-IDE
  • De novo
  • Humanitarian Device Exemptions (HDE)
  • Combination Product
  • IND
  • Pre-IND
  • ANDA
  • Orphan Drug
  • 505(b)(2)
  • Pre-Submission meetings
  • Panel meetings
  • Negotiating clinical trials
  • Negotiating labeling
  • Modifications
  • MDR
  • Adverse event reporting
  • Form 2253 submission
  • CE Marking
  • CER filing
  • Appeals and Citizen Petition
  • Requests for Designation
  • Performing mock inspections
  • FDA meetings
  • Crisis management
  • Recall assessment, strategy and management
  • Part 806 corrections and removals
  • Health Hazard Evaluations
  • Process development
  • Facility planning and moves
  • Design transfer
  • Supply chain audits and qualification
  • Project management

January 2020: Did you miss these important 2019 FDA medical device guidance documents?

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