Injectech can provide information essential to addressing your projects' design, regulatory, and technical requirements. We can assist with engineering solutions, selecting the correct resin for the application, product certifications, drawings, regulatory compliance documents, and DHR files.
Standards and Certifications
ISO Certified: 13485
Injectech's ISO 13485 certification is an extension of our commitment to quality, our customers and our philosophy. Injectech is Certified by Orion Registrar.
Orion is internationally accredited by the United States ANAB, and the Dutch Council for Accreditation (RvA). Each of these accreditations is recognized throughout the world for Quality and Environmental Programs. In addition, all of our auditors are qualified to the International Registrar of Certified Auditors (IRCA) or the RABQSA requirements.
Class 8 (100,000) Clean Room
All medical products manufactured by Injectech, LLC are molded and/or assembled in our certified Class 8 (100,000) clean room.
Our products are double bagged and labeled prior to leaving our clean room.