Factory Tour
To apply these standards in production, Nenwell Biomedical should ensure that their product meets all the required specifications outlined in each standard. This may include testing the product under specific environmental conditions, implementing a robust quality control system, and obtaining necessary certifications and approvals from regulatory bodies. The manufacturer should also provide clear instructions and documentation for the proper use, installation, and maintenance of the product to ensure that it functions safely and effectively for its intended purpose.
1. ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
2. WHO PQS E003/004 - Performance, quality and safety specifications for insulated containers
3. EN 60068-2-38 - Environmental testing - Part 2-38: Tests - Test Z/AD: Composite temperature cyclic test
4. EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
5. US Food and Drug Administration (FDA) standards for medical devices