Kapstone Medical is ISO 13485:2016 certified, meaning that we have been recognized by the International Organization for Standards as being compliant with their international quality standards. For Kapstone, a contractor and consultant firm, this is a unique achievement that underscores our commitment to quality standards. Our subsidiary company, Kapstone Manufacturing, is also ISO 13485 certified.
Kapstone Medical’s regulatory specialists hold the Regulatory Affairs Certificate (RAC), the only post-academic credential available to regulatory professionals in the healthcare industry. In order to earn a RAC, medical device and development professionals must demonstrate knowledge in global regulatory requirements (FDA, CE Mark) and ISO standards. Certification shows that the certified individual can be considered an expert in regulatory affairs.
Computer-Aided Design (CAD) Certifications show that an individual is proficient in design and rendering software. Kapstone Medical’s product development engineers utilize the SolidWorks CAD platform and have been certified at the Professional level in Mechanical Design.
The U.S. Food and Drug Administration (FDA) requires all companies involved in the production and commercial distribution of medical devices to complete an annual registration. In order to register, these companies must provide the locations of their various medical device production facilities and descriptions of the devices manufactured at each one. When public, this knowledge ensures that the FDA can efficiently marshal healthcare resources in the event of a national health crisis.
Kapstone Medical (through our subsidiary Kapstone Manufacturing) annually renews our own registration with the FDA which exhibits our compliance in the industry and our comfort to assist our many customers who also need proper establishment registration.