US FDA QSR (GMP) 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 Regulation (QSR). The FDA QSR (21 CFR Part 820) includes a requirement for manufacturers to implement a quality system for the design, manufacturing, packaging, labeling, storage and delivery of medical devices. This regulation is also widely known as Good Manufacturing Practice (GMP).
Emergo Group has implemented hundreds of FDA QSR compliant quality systems for medical device and IVD manufacturers in the United States, Europe, Canada, China, Australia and elsewhere. Our team of FDA consultants and Certified Lead Auditors has implemented QSR (GMP) quality management systems for companies manufacturing a wide range of products.
Why choose Emergo Group as your FDA consultants?
- All of our FDA quality management systems are fully customized to your business needs. They are not "off the shelf" solutions.
- Our quality management systems are fully compliant with the FDA Quality System Regulations(QSR).
- 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 FDA QSR consulting and project management team work together to deliver your quality 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 quality management system.
- No surprises: Most of our projects are based on a fixed price, not an open ended "time and materials" basis.
Let Emergo Group's consulting team put you on the path to FDA compliance and open the doors to new sales opportunities in the United States and worldwide.
Contact us today for more information on our FDA Quality System Regulation (GMP) consulting services.
