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
Email: mdci@m-dci.us
Website: http://m-dci.us