MED-DEVICE CONSULTING INC. HAS THE UNIQUE CAPABILITY OF ASSISTING COMPANIES IN:

• Identifying potential concerns and opportunities specific to their business posed by ever-increasing governments and agency involvement. We develop specific strategies and tactics to cope with these pressures and capitalize on the opportunities. Our service translates into cost-effective modifications, increased productivity and client profitability.
• The process of startup manufacturing, distribution, obtaining FDA Clearance, ISO certifications, product CE Mark, compile the Cosmetic Product Information File (P.I.F.) and focus on the technical regulations, which are presently enforced, and must comply with the FDA and most recent update EU Directives.
• providing modeling of Standard Operating Procedures (SOP’s), Design Control procedures to achieve and implement successful regulatory compliances and Design Control program.
• The principles of risk management for product and devices to comply with government agencies, FDA and the new International regulations. The Risk Analysis assistance methods we provide can be applied to all aspects of Product Design including mechanical, electronics, microprocessor, software, Capital Medical Devices equipment and Medical Devices disposables.
• Regulatory scrutiny has become increasingly more sophisticated and in-depth.  Medical device, cosmetic, personal lubricant, and nutraceutical / dietary supplement manufacturing processes gain considerable attention during agencies manufacturing inspections/audits and FDA submission reviews and requests for additional information and documentation are frequent.  Med-Device Consulting, Inc. will provide complete assistance by preparing methods for implementing and maintaining a successful Control program to comply with current regulations.
• Companies that understand these requirements will have a significant competitive advantage in obtaining rapid approvals in the U.S. and the European market.  Whether your company’s products are already on the market or currently in development, Med-Device Consulting, Inc. will help in achieving compliance, receiving the FDA approval process and the most recent update ISO, preparing and maintaining CE Mark files and compiling the cosmetic products’ clients with the Product Information File (P.I.F.) that must be prepared and submitted to a qualified EU Responsible Person.