High Quality STD Rapid Test Kits: ISO 13485 and GMP Certified.
Here, find quality and precision in our ISO 13485- and GMP-certified STD rapid test kits. Manufactured to stringent standards in state-of-the-art facilities, these test kits ensure 98-99% accuracy in detecting common sexually transmitted infections like chlamydia, gonorrhea, and syphilis.
01 October 2024
3 min read
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Understanding ISO 13485
ISO 13485 is an international quality management standard recognized globally by FDA and WHO. It decides the quality parameters for design and manufacturing of medical equipment. ISO 13485 is a process-based, not product-based standard. This means that it governs the journey which a product undertakes to reach the market.
Though different countries may have their own requirements related to quality control, ISO 13485 is considered the main QMS standard for medical devices.
Implications of ISO 13485 Certification
ISO 13485 Certification simply means that an organization has gone through the scrutiny of a qualified organization and has been able to fulfill all the requirements mentioned in ISO 13485. ISO 13485 certification simply reflects the efficiency of a company's QMS and also its suitability for a medical device design and manufacturing system.
Become ISO 13485 Certified
To gain an ISO 13485 certification, a manufacturing firm has to undergo a third-party MDSAP audit-which stands for Medical Device Single Audit Program. Upon gaining it, the validity lasts for three years, after which the company must undergo re-evaluation and re-certification. However, annual inspections of the design and manufacturing process are made by ISO committees and staff.
The ISO 13485 and GMP-certified products assure consumers of their quality in design and manufacturing processes. Continuing annual inspection by ISO committees and staff further guarantees legality and safety, thus allowing consumers to confidently purchase such products.
Understanding the TUV Rheinland Certificate
Technischer Überwachungsverein Rheinland-or TUV in short-is a safety standard applied across various safety-critical areas. As a globally acknowledged certification body, TUV Rheinland prescribes requirements for personnel, product safety, and companies. TUV Rheinland is a distinguished member of the International Federation of Inspection Agencies, and its certification scheme adheres to the ISO/IEC 17067:2013 standards.
The Value of Good Manufacturing Practices (GMP) Certification
GMP certification provides the assurance of controlled production for a certain product made according to specific globally recognized standards that assure its quality. It is an important certificate that helps in increasing consumer confidence in the product's quality.
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