|
As a private label service provider, KMC operates exclusively through
focused, project-oriented, multidiscipline teams, providing flexible
and responsive support services designed to meet your needs and
ensure high-quality products.
Engineering
We provide a broad range of engineering support services to
meet your changing needs. Development capabilities range from complete
systems and major subassemblies to instrument enhancements, feasibility
studies, and design reviews.
Production
Our production support services include complete instrument assembly
and performance testing, strategic material sourcing, purchasing
and inventory management, spare parts management, depot repair,
and instrument refurbishment.
Quality
Our quality assurance support services include design verification
and validation, design reviews, risk analysis, FMEA, DOE, and technology
transfer to manufacturing. Other areas of expertise include statistical
process control, gauge R&R studies, process capability studies,
and proficiency in safety requirements such as UL and CSA compliance.
Our ISO 13485 certification is our backbone with respect to quality
system compliance.
Regulatory
Our regulatory expertise includes in-depth knowledge of FDA standards,
EU directives, and other worldwide medical device regulations. We
assist in the development of necessary documentation to support
FDA, EU, Canadian, and Asian regulatory approvals, as well as interface with appropriate regulatory agencies.
|
 |
