Certifications are not only necessary when you select an outsource manufacturer, they provide a foundation for the confidence and trust that will grow as you work closely with our team. Evolve is proud to pass audits with flying colors and maintains its prestigious standing with the British Standard Institute (BSI) certifications process. In addition, we are ITAR certified (required for many defense projects), and meet United States Food and Drug Administration (FDA) Quality System Regulation requirements. In addition, Evolve is proud to be on the Women's Business Enterprise National Council (WBENC) certification list and can meet your requirements for fair-bidding and outsourcing practices.
With the following certifications to our name, we have built a reputation for providing 100% on-time delivery and 99.7% out-of-box quality.
ISO 9001 Certified
This British Standard Institute (BSI) certification is recognized world-wide as a mark of distinction. ISO 9001 Certification affirms the quality-management system is defined, documented and effectively implemented to meet Customer requirements. An ISO 9001 requirement is ensuring continuous improvement and confirming Customer Satisfaction. Evolve fully embraces these requirements to improve internal and Customer processes to improve productivity, reliability and reduce costs.
ISO 13485 Certified
Without the BSI certification, a company is not entitled to build medical products or equipment. ISO 13485 tells a customer that Evolve staff has been through proper training and can provide the thorough documentation in the event of an audit. With Evolve's certification status standing by you, you can be certain that your product is produced in a verifiable way. That should give you a sigh of relief!
The United States Food & Drug Administration officially authorizes the manufacture of medical devices. Evolve is registered with the United States FDA and California State FDB as a contract manufacturer of medical devices. Evolve has undergone and passed all inspections for the manufacture of medical devices.
ITAR mostly applies to defense projects, as well as a few other government regulated agencies such as NASA. It reflects a government standards and policies: for example, none of the parts used in the manufacturing process can be bought from embargoed countries. We stay on top of the latest rules to keep our ITAR registration current and valid.
Women's Business Enterprise National Council (WBENC) provides national recognition and certification of minority and women-owned businesses. In the past few decades, this has become important to many companies, agencies, and municipalities seeking government, and even many corporate, contracts. Founded by Noreen King in 1999, a machinist's daughter, Evolve is proud to be a woman-owned company.
Evolve has developed a Quality Management System that complies with all requirements of the Quality System Regulation. Evolve employee's have decades of medical device experience to ensure that the Systems and Processes used for medical devices continue to meet regulatory requirements. Evolve routinely works with start-up medical device businesses to assist with developing systems and processes to ensure regulatory requirements are met.