Our ISO 13485 and GMP certified STD rapid test kits
All our rapid test kits are manufactured in the most advanced and modern facilities that operate under GMP and the ISO 13485 Medical Device Standard. Meeting all the requirements set by ISO 13485 regarding their design and manufacture, they are 98-99% accurate in detecting some of the most common sexually transmitted diseases, such as chlamydia, gonorrhea, and syphilis.
What is ISO 13485?
ISO 13485 is an FDA and WHO-approved international standard for quality management. In other words, ISO 13485 is a widely-used system that states the requirements for the design and manufacture of Medical Devices, setting the quality standards of the Quality Management System (QMS). This system is effectively setting the quality criteria for the medical device industry. ISO 13485 is a process-based standard, meaning that it controls the process a product went through to reach the market. Therefore, ISO 13485 is not a product-based standard. Although many countries have their own regulations about quality control, ISO 13485 remains the main QMS standard for medical devices.
What does ISO 13485 certified mean?
When a company is ISO 13485 certified, it means that it went through an ISO 13485 Quality Management System, by an organization in charge and has successfully met all the ISO 13485 requirements. In other words, it means that your QMS is effective and meets the criteria for the design and manufacture of medical devices.
How does a manufacturer get an ISO 13485 certification?
To get an ISO 13485 certification, a manufacturer has to pass a third-party Medical Device Single Audit Program or “MDSAP” audit. Every certification lasts for three years. The company must be re-evaluated and re-certified after three years. However, the design and manufacturing process is inspected annually by ISO committees and staff.
What ISO 13485 mean to the consumer:
ISO 13485 and GMP certified products have a legal and high-quality design and manufacturing process, inspected annually by ISO committees and staff. Consumers can purchase such products safely.
TUV Rheinland certificate
Technischer Überwachungsverein Rheinland (TUV) is a safety-based standard, applied to a variety of safety-relevant areas. TUV Rheinland is a globally recognized certification body that sets the requirements for personnel, companies, and product safety. TUV Rheinland is a member of the International Federation of Inspection Agencies. Its certification scheme follows the ISO/IEC 17067:2013.
Good manufacturing practices (GMP) certification
The good manufacturing practices (GMP) certificate ensures the consumer about the product's controlled production, according to specific, widely-recognized quality standards.