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Greg Godfrey & Associates

Contact:  Greg Godfrey, RAC, CQE, CQA - Owner & Principal Consultant
Specialty: Devices


Years in business:  16





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Greg Godfrey & Associates is a medical device consulting network of Executive and Senior level individuals specializing in medical device regulatory affairs, quality assurance, and product engineering.

  • FDA GMP, ISO 13485, MDD 93/42/EEC implementation & compliance
  • Strategic QARA development and support for start-up medical device companies
  • 510(k) development and submission
  • Technical file / dossier development support
  • IEC 60601-1 certification
  • ISO 9001 implementation
  • Canadian license applications, European CE marking requirements
  • State of California DPH compliance and manufacturing license support
  • Risk management, ISO 14971 compliance
  • Product recalls and safety alerts
  • Product complaint investigation, MDR and Vigilance report submissions
  • FDA and international regulatory agency interaction
  • Response to regulatory agency notice of adverse findings (FDA 483, Warning Letters, Notified Body audits)
  • TQM, process improvement
  • Acquisitions and due diligence
  • Plant and technology transfers
  • UL/CSA product certifications
  • Internal Audit programs, Internal audits, Internal audit training
  • Supplier development and audits
  • Document control and related subsystems
  • Product development and product engineering
  • Product, process, facility qualification and validation
  • GMP/Quality System Training
  • CAPA systems and root cause investigation