MED-DEVICE CONSULTING, INC.

PROVIDING WORLD-CLASS SERVICES
Primarily in the Medical Device, Personal Lubricant (510(K) guidance and submission, including manufacturing operations), Cosmetic Products - Skincare flavored heating massage lotions, Arousal Serum, Skincare and aromatherapy heating massage oils.  and Nutraceutical / Dietary Supplement Fields.

Med-Device Consulting, Inc., with over 30 years of experience, provides a wide range of personalized regulatory and quality assurance consulting services that meet your company’s needs and help manufacturers in their regulatory affairs for marketing and distributing their products in the United States and Europe. We support the company’s needs for the FDA Quality Assurance and Regulatory systems, MDSAP Audit program, EU MDR and CE mark preparation, 510(k) submissions, and ISO 13485 Quality system preparation for certification.

OUR COMPANY AT A GLANCE
An experienced, focused, and flexible consultant of experts who will help see your project through to completion the right way.
• Complete Quality System development FDA and ISO 13485:2016 consulting and gap analysis. Part 11, 210, 211, and 820 Compliance review. If applicable, review the quality system, then develop and implement a remediation plan.
• MDD transition to MDR, MDSAP, and CE medical device safety consulting
• Device Class and Regulatory Controls: Class I General Controls, Class II General Controls and Special Controls, Class III General Controls and Premarket Approval
• Establishment Registration
• Medical Device Labeling and UDI submission
• FDA Registration Certificate and Renewal. Facility registration - domestic and international.
• FDA Agent Requirements and Agent Services
• Internal audits, supplier audits, and assessments.
• Corporate strategy implementation.
• Training: GMP, Quality System Regulation, Design Control, Process Validation, Compliance programs, MDSAP, MDD, IVDR, ISO 13485, and ISO 14971.
• Establish supplier/vendor chain management programs. Conduct client/supplier audits.
• Due diligence evaluations for acquisition and investment.
• Set up domestic and international operational manufacturing and quality assurance.
• Consent Decree and “483” Remediation. FDA Inspection 483 and Warning Letter, responses, and corrective action plans.
• Product recall assistance.
• cGMP Compliance/ Mock FDA inspections / mock Pre-Approval Audit and Readiness Assessments.
Contact Information: email: mdci@m-dci.us or (818) 585-7488