Regulatory Credentials
KMC Systems has in-depth knowledge of FDA standards, EU directives, and other worldwide medical device regulations. All design and manufacturing projects are supported by knowledgeable professionals to ensure medical devices and instrumentation meet quality standards and comply with regulations. We assist with the regulatory approval process through the development of necessary supportive documentation and interfacing with appropriate agencies.
Our regulatory credentials include:
- ISO 13485 certification
- Registration with FDA as a GMP manufacturer
- Compliant with FDA Quality System Regulations
- Compliant with EU directives for IVD devices and MDD devices requiring CE Mark
- Experience with Class I, II, and III devices
