Med-Device Consulting, Inc.
Med-Device Consulting, Inc.
Quality / Regulatory Consultancy Organization
Contact:
Louie Goryoka, ISO Certified Lead Auditor, CQE, MBA
Senior Consultant
About Med-Device Consulting, Inc.
Med-Device Consulting, Inc. is a quality and regulatory consultancy organization
specializing in U.S. FDA and international quality and regulatory compliance
programs for medical device, IVD, cosmetic and personal lubricant manufacturers,
as well as nutraceutical, food, and dietary supplement organizations.
Services & Expertise
- Emergency Use Authorization (EUA) of medical products and related authorities, including PPE submissions and biocompatibility test examination support
- Complete Quality System development and implementation
- FDA, ISO 13485:2016, MDSAP and CE medical device compliance consulting
- CE Mark Technical File preparation and maintenance
- FDA and regulatory audits, including PAI gap analysis, MDSAP, MDR and supplier audits
- Validation programs and compliance support
- 510(k), PMA and CE Mark preparation and submission support
- ISO 9000, ISO 13485, MDD and MDR preparation, implementation and review
- Consent Decree and FDA Form 483 remediation
- 21 CFR Part 11, 210, 211 and 820 compliance support and review
- GMP, Quality System Regulation, Process Validation and regulatory compliance training
- MDSAP, MDD, ISO 13485, ISO 9001 and ISO 14971 training
- Supplier and vendor chain management programs
- Due diligence evaluations for acquisitions and investments
- Corporate strategy implementation
- Device classification and R&D portfolio analysis
- Independent design control review
- Risk assessment and hazard analysis
- IEC 60601 safety and usability study preparation and submission support
- Establishment registration, FDA registration certificates and renewals
- FDA Agent Services and Export Certificates
- Food, dietary supplement and medical device labeling review
- UDI submission support
- Subject Matter Expert support for small and large manufacturers
- Failure Mode and Effects Analysis (FMEA) and ISO 14971 risk management
- Design of Experiments (DOE)
- CAPA program implementation
- Cosmetic Product Information File (PIF) assembly and compilation
- Cosmetic ingredient profiles and Product Safety Assessments
Experience
Over 30 years of experience in domestic and international
quality and regulatory requirements, including extensive Lead Auditor experience.
Contact
Louie Goryoka
Med-Device Consulting, Inc.
Phone:
+1 (818) 585-7488
Email:
mdci@m-dci.us
Website:
m-dci.us