Regulatory agencies, by law, require the implementation of Quality Management Systems to preserve public safety and ensure the manufacture of licensed or cleared products. When implemented properly, Quality Management Systems enable you to operate as a medical device or life science company, while achieving the auditable standards necessary to market your product.
At MethodSense, we’ve developed practical regulatory solutions which allow you to meet high levels of product quality and auditability.
Our experience spans:
- Quality Management Needs and Gap Analyses
- Quality Management System Creation and Implementation
- 21 CFR Part 820, ISO 13485, 14971, 9001 and more
- Certification Management and Follow Up
- Quality as a Service
It’s important to note that companies globalizing products across the pond must harmonize their QMS with other regulations… ISO 13485 to 21 CFR Part 820 or vice versa. Companies are also increasingly required to integrate multiple regulations, such as Part 820 and HIPAA and other privacy regulations, in a more streamlined and efficient system.
SCHEDULE AN APPOINTMENT WITH ONE OF OUR QUALITY MANAGEMENT CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay.