quality
Mission Statement
To be recognized as a partner to our customers by collaborating with scientists to develop and provide innovative products and services that help advance diagnostics technologies to improve global healthcare.
Quality Policy
ZeptoMetrix is committed to understanding, implementing, and maintaining quality at all levels within the organization. ZeptoMetrix is committed to meeting or exceeding customer requirements while adhering to applicable standards and regulatory requirements, and maintaining the effectiveness of the quality management system. This Quality Policy serves as a framework for establishing and reviewing ZeptoMetrix quality objectives.
ISO 13485
- ZeptoMetrix Buffalo and Franklin are ISO 13485 certified medical device manufacturers. This standard presents the requirements for a comprehensive quality management system for the design, development and manufacture of medical devices.
- Maintaining this certification demonstrates ZeptoMetrix’s commitment to its quality management system and our ability to consistently design, develop, manufacture and distribute in-vitro diagnostic medical devices.
ZeptoMetrix Franklin,MA ISO 13485:2016 Certificate
ZeptoMetrix Buffalo,NY ISO 13485:2016 Certificate
FDA Registered Medical Device Establishment
- ZeptoMetrix Buffalo and Franklin sites are FDA registered medical device facilities committed to adhering to all applicable Current Good Manufacturing Practices (CGMP) as outlined in FDA 21 CFR Part 820.
- This regulation applies to the manufacturing facility, processes, and controls used for the design, development, manufacture, labeling, packaging, storage, and distribution of our in-vitro medical diagnostic products.
CE Mark
- ZeptoMetrix Franklin is currently producing a line of in vitro diagnostic external run controls for use with molecular diagnostics assays that are CE marked and thus conducive to importation into EU member countries.
- The CE mark indicates conformity with the essential requirements set forth in the European In Vitro Device Directive, IVDD 98/79/EC.
IVDR -EU Quality Management System Certificate