Supply Chain

Because Hibernicor is a medical device manufacturer of finished products designed for human use, it critical that we partner with suppliers who can help meet our goals.  We recognize that our suppliers are integral of the quality process and have central role in providing innovative high quality & low cost medical products.  It is important that our global suppliers are able to maintain standardized controls in the work environment to ensure product safety.  These include documenting and validating processes during product design, development, and manufacturing, as well as verification of the effectiveness of corrective and preventative actions.

Such standards include:

ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
FDA 21 CFR Part 820 Quality System Regulation – Medical Device Good Manufacturing Practices
ISO 9001 Quality management systems – Requirements
MIL-STD United States Military Standards
NIST National Institute for Standards and Technology
DIN Deutsches Institut für Normung e.V. (German Institute for Standardization)

Hibernicor maintains a reference library of regulatory standards and specialized guidance documents which is available to qualified suppliers.