Med-Device Consulting, Inc. (M-DCI)

Med-Device Consulting, Inc. (M-DCI) is a consulting firm offering the medical device, pharmaceutical, biotechnology over-the-counter (OTC) industries, commercial sectors in electronics, electromechanical, and injection molding industries with highest technical proficiency and global regulatory experience bringing numerous products to market both economically and effectively. Med-Device Consulting, Inc. additionally provides personalized regulatory and quality assurance services that meet your company needs including U.S. Agent Representative and Official Correspondent.

 

These are samples of our services.

• QSR, ISO 9000, ISO 13485, ISO 17025, ISO 14971 and MDD
• Implementation/Certification Regulatory Compliance/Audits-Internal and Supplier Audits and Assessments
• QA/QC Compliance
• FDA Inspection Preparation
• Facility registration - Domestic and International
• Setup Domestic and International operational manufacturing and quality assurance
• Device Submission 510(k)s, INDs, IDEs, PMAs
• Trouble Shooting: 483's, Warning Letters, Import Detentions
• Preparation of Technical File for product CE Mark submission/registration
• Establish Supplier/Vendor Chain Management Programs
• Analytical business, management and quality planning
• Due Diligence Evaluations for Acquisition and Investment
• Establishing startup business/operations
• Project Management, Process Engineering & Reengineering
• Writing persuasive corporate manuals, policies and procedures
• Failure Mode and Effects Analysis (FMEA)
• Design of Experiments (DOE)
• CAPA program implementation
• Process Capability (CP & Cpk) studies
• Equipments, Software and Sterilization Validations
• Developing and implementing documentation systems, which includes quality manuals, SOP’s, validation protocols, manufacturing processes, inspection and testing methodologies to comply with ISO standards, FDA cGMP and 21 CFR Part 11 regulations.

Med-Device Consulting, Inc.  is seasoned and broad background knowledge in QSR/GMP for medical technology start up ventures, distribution, contract negotiation for domestic and International medical devices and pharmaceutical products.

Med-Device Consulting, Inc. provides an interdisciplinary approach to assisting industries regulated by FDA and international health agencies. Med-Device Consulting, Inc. mission to only offer the very best services in the most cost effective way while providing an accurate and truthful explanation of the regulations, directing quality and compliance strategies, preparing and reviewing quality/regulatory submissions, providing procedural and scientific assistance, performing ISO, GMP and QSR audits, certifications and assessments, and delivering customized training seminars to our clients.