FDA GMP (cGMP) Quality System Implementation Consultants
Medical devices manufacturers who want to sell their products in the United States must comply with the US Food and Drug Administration Quality System Regulations (QSR). The FDA QSR (21 CFR Part 820) includes a requirement for manufacturers to implement a FDA GMP (cGMP) compliant quality system for the design, manufacturing, packaging, labeling, storage and delivery of medical devices. FDA GMP stands for Food and Drug Administration Good Manufacturing Practices, It is also referred to as cGMP, or current Good Manufacturing Practice.
Emergo Group has implemented hundreds of FDA GMP (cGMP) compliant quality systems for medical device and IVD manufacturers in the United States, Europe, Canada, China, Australia and elsewhere. Our team of quality system consultants and Certified Lead Auditors has implemented FDA GMP systems for companies manufacturing a wide range of medical devices. We work closely with our clients to determine their business needs, custom tailor a system that meet the GMP regulation requirements, and make sure the quality system gets implemented on schedule and on budget. Although we customize our GMP solutions to every client, we have been through the process with so many medical device and IVD companies that we can assure you that if you follow our guidance you will be in full compliance.
Why choose Emergo Group to implement your FDA GMP (cGMP) quality system?
- All of our FDA GMP systems are fully customized to your business needs. They are not ”off the shelf” solutions.
- Our quality systems are fully compliant with FDA Quality System Regulations (QSR).
- Our systems can also meet the full compliance requirements of the European CE Marking and Canadian Medical Devices Regulations (if desired) at no additional cost.
- Our consultants and project management team work together to deliver your FDA GMP system on time and within budget.
- We are always accessible to you and provide unlimited support during your project, on site and off site.
- On-site training for your key employees is included in the cost of the FDA GMP (cGMP) quality system.
- No surprises: All of our projects are based on a fixed price, not an open ended “time and materials” basis.
- 95% of our clients work with us year after year, a testament our dedication to providing superior customer service.
We provide unlimited phone support during the implementation in addition to your on-site technical support. Let Emergo Group put you on the path to FDA GMP compliance and open the doors to new sales opportunities in the United States and worldwide.
