Med-Device Consulting, Inc., Quality/Regulatory Consultancy Organization

Contact:  Louie Goryoka, ISO Certified Lead Auditor, CQE, MBA - Sr. Consultant

Med-Device Consulting, Inc. is a quality/regulatory consultancy organization in U.S. FDA and International quality and regulatory affairs compliance programs for the medical device, IVD,  Cosmetic and personal lubricant Manufacturer, and Nutraceutical / Food / Dietary Supplements.

Service and Expertise include:

  • Emergency Use Authorization of Medical Products and Related Authorities (EUA submission) Expertise: PPE submissions, Biocompatibility tests examination support
  • Complete Quality System development FDA, ISO 13485:2016, MDSAP, and CE medical device safety consulting, Preparing and maintaining CE Mark Technical Files
  • Consulting and audits: PAI gap analysis, Auditing Services (FDA, PAI, MDSAP, MDR, Supplier, others), Validation programs, CEA Certification Support, including preparations and submissions 510(k)s, PMAs, CE Marks
  • ISO 9000, ISO 13485 and MDD / MDR preparation, implementation, review
  • Consent Decree and “483” Remediation
  • Part 11, 210, 211 and 820 Compliance support / review
  • Training: GMP, Quality System Regulation, Process Validation, Compliance programs, MDSAP, MDD, ISO 13485, ISO 9001 and ISO 14971
  • Establish supplier/vendor chain management programs
  • Due diligence evaluations for acquisition and investment
  • Corporate strategy implementation
  • Device Classification, R&D Portfolio Analysis / Independent reviewer Design Control,
  • Risk assessment & hazard analysis, Safety IEC 60601, Usability Study preparations and submissions
  • Establishment Registration, FDA Registration Certificate, FDA Registration Renewal, FDA Agent Services, Export Certificates
  • Food and Dietary Supplements / Medical Device Labeling Review
  • UDI submission
  • Subject Matter Expert (small & large manufacturer)
  • Failure Mode and Effects Analysis (FMEA); Risk Management per ISO 14971
  • Design of Experiments (DOE)
  • CAPA program implementation
  • Cosmetic Product Information File (PIF) assembly and Compilation, submission/registration
  • Cosmetics ingredient profiles;
  • Cosmetic Product Safety Assessment

Years in Business: Over 30 years of experience in domestic and international regulations, and Lead Auditor

Work Phone: +1(818) 735-0488