Regulatory compliance

Regulatory compliance is an essential part of Croom Medical’s operations. We are dedicated to maintaining compliance with all relevant regulations, standards, and guidelines in the orthopedic implant industry. Our Quality Management System is designed to ensure that our products meet or exceed regulatory requirements, including ISO, FDA and EU regulations, and our team is trained and experienced in navigating the regulatory landscape. We conduct regular audits and maintain thorough documentation to ensure that we are consistently meeting regulatory requirements. Our commitment to regulatory compliance gives our OEM customers peace of mind, knowing that their products are manufactured to the highest quality standards and in full compliance with all applicable regulations.

510K submission support

Croom Medical provides comprehensive 510(k) submission support services to assist our OEM customers in navigating the complex regulatory landscape of the medical device industry. Our experienced regulatory team has a deep understanding of FDA regulations and requirements and can provide guidance throughout the entire submission process. We offer support for traditional, abbreviated, and special 510(k) submissions, as well as pre-submission meetings with the FDA. Our team can also assist with post-approval compliance and ongoing regulatory support. With Croom Medical, OEM customers have a trusted partner for 510(k) submission support, ensuring that their products meet the highest standards of safety and efficacy.

ISO 13485 & ISO 14001

ISO 13485 is a standard for medical device quality management systems, while ISO 14001 is a standard for environmental management systems. Croom Medical is committed to complying with both of these important standards to ensure that our products are safe, reliable, and environmentally responsible. Our quality management system is designed to meet the requirements of ISO 13485, while our environmental management system is aligned with the principles of ISO 14001. This commitment to quality and environmental responsibility is integral to our overall mission of providing high-quality orthopedic implant solutions while minimizing our impact on the environment.