Manufacturers who want to sell their medical devices or IVDs in the United States must comply with 21 CFR Part 820 of US law. This section of the US Code of Federal Regulations specifies the quality system requirements for medical device and IVD manufacturers and is commonly referred to as the FDA GMP (Good Manufacturing Practice). FDA GMP for medical devices requires manufacturers to implement a quality system for the design, manufacturing, packaging, labeling and storage of the products.
Emergo is an experienced FDA GMP consulting firm that has implemented hundreds of GMP and ISO Quality Management Systems (QMS) for medical device and IVD manufacturers in North America, Europe and Asia. Our FDA GMP consultants have implemented quality management systems for companies with a diverse range of medical devices and manufacturing processes. Also, our consulting team is equally experienced with ISO 13485 and we typically implement it at the same time an FDA GMP system is being established. This allows companies to have a seamlessly integrated FDA compliant quality system that also meets international requirements for Europe, Canada, Japan, Australia and more. If you already have ISO 13485:2003 certification, we can assist you in integrating FDA Good Manufacturing Practice into your existing QMS.
Why choose Emergo for your FDA GMP consulting projects?
- All of our FDA GMP medical device quality management systems are fully customized to meet your business needs. They are not "off the shelf" solutions or based on package software. Our quality management systems are fully compliant with the FDA Quality System Regulations.
- We specialize in helping small- to medium-size companies implement FDA GMP cost effectively.
- Our quality management systems can also meet the full compliance requirements of the European CE Marking, Canadian Medical Devices Regulations, and Japanese Pharmaceutical Affairs Law and MHLW Ordinance #169 (if desired).
- Our consulting and project management teams work together to deliver your QMS on time and within budget.
- We are always accessible to you and provide support during your project, on site and off site.
- On-site training for your key employees is included in our FDA GMP consulting fees.
- No surprises: Most of our projects are based on a fixed price, not an open ended "time and materials" basis.
Let our FDA GMP consulting team put you on the path to compliance and open the doors to new sales opportunities in the United States and worldwide.