QUALITY MANAGEMENT
Accreditations
At Sheffield Precision, we take pride in our commitment to meeting and exceeding the ever-evolving global requirements for medical devices. Each year, we invest in staying ahead of these changes, ensuring that our processes and practices remain at the forefront of industry standards. Our team consists of experienced inspectors supported by a highly motivated Quality Assurance (QA) team comprising quality and validation engineers.
We are proud to hold several accreditations that demonstrate our dedication to quality and compliance:
- ISO 13485:2016 Certification: Sheffield Precision is certified to ISO 13485:2016, an internationally recognized standard for quality management systems specific to the medical device industry. This certification reflects our commitment to maintaining the highest quality standards in our products and services.
- FDA Registration with Emergo: Sheffield Precision is registered with the U.S. Food and Drug Administration (FDA), with Emergo serving as our agents. This registration highlights our compliance with FDA regulations, further reinforcing our commitment to meeting regulatory requirements in the United States.
- Japanese Foreign Medical Device Manufacturer: Sheffield Precision holds registration as a foreign medical device manufacturer in Japan. This registration underscores our ability to meet the regulatory requirements of one of the world’s leading markets for medical devices.
Registered by Japanese Minister of Health, Labour, and Welfare
