A typical Initial Importer buys products from foreign manufacturers and introduces them into the United States market; therefore, they are subject to FDA controls. A large percentage of these companies are small entities with limited resources. As a result, many are operating in varying states of noncompliance.
Recognizing Initial Importers need help with meeting the FDA requirements, GPMG developed a series of procedures aligned with the typical Initial Importer resource structure. The procedures were then refined to reduce the effort and time required to execute the process steps contained within each procedure. The resulting product was a realistic system that meets the FDA requirements upon installation and helps ensure continued use.
Current FDA efforts to reduce the amount of adulterated product entering the United States is leading to an increased emphasis on the supply chain. Initial Importers will undoubtedly face increased scrutiny over their business activities in the coming years. Providing a solution to these compliance challenges is a benefit to everyone involved, including the public.
Initial importers play an important role in the medical device supply chain. GPMG is confident that current and future Initial Importers will take full advantage of this practical and cost-effective compliance solution.
The Initial Importer operating system includes detailed procedures for:
- Complaint Handling and Trending
- Medical Device Reporting
- Remedial Action / Recall
- Product Hold
- Supplier Management
- Document and Change Control
- Management Review
- Corrective and Preventative Action
- Internal Audits
- Training and Job Descriptions
Global Pacific Manufacturing Group LLC is a privately held medical device consulting firm that assists medical device manufacturers of all sizes with product development and regulatory compliance globally.
To learn more about Global Pacific Manufacturing Group LLC products and services visit them at: www.gpacmfg.com
Media Contact Information:
Global Pacific Manufacturing Group