GIGALAB® successfully completed the recertification audit for CE Mark Certification. The scope of the certification includes Product: – GLD COVID-19 Ag test GLD HIV 1+2 test GLD HCV TEST GLD HCG TEST GLD HBs Ag test GLD SYPHILIS Ab test GLD Monkeypox Virus Ag test.
Apart from this, GIGALAB® can also apply for ISO 14001:2015 Certification for Environmental Management System (EMS) and Energy Management System (EnMS) to adopt renewable and safe energy resources to ensure eco-friendly business practices. The organization can obtain ISO/IEC 27701:2022 certification to demonstrate its commitment to safeguarding vendors’ and clients’ data and other valuable information.
GIGALAB® can apply for ISO 41001:2018 Certification for Facility Management -Management System.
What is CE Mark Certification?
CE Mark Certification is a designation used within the European Economic Area (EEA) that shows a product meets high health, safety, and environmental protection standards. “CE” stands for “Conformité Européenne,” meaning “European Conformity.” When a product carries the CE mark, it has been evaluated to ensure compliance with EU legislation and is approved for free movement within the EEA.
CE marking applies to various product categories, including medical devices, electronics, toys, and construction materials. CE certification can open doors for manufacturers in European markets, as it signifies that a product has met essential safety and regulatory requirements.
Benefits of CE Mark Certification for GIGALAB®
GIGALAB® can obtain the following benefits by adopting CE Mark Certification. These are as follows:
- CE Mark certification acts as a passport for medical products, allowing them to be legally sold across European markets. This standard opens doors to international markets for GIGALAB®, enabling broader distribution and access to more patients and healthcare providers.
- The CE Mark assures that GLD diagnostic tests, including HBs Ag and Syphilis Ab tests, meet high safety and reliability standards. This inspires confidence in users and ensures consistency by producing dependable results in medical settings.
Conclusion
GIGALAB®’s achievement of CE Mark Certification underscores its commitment to providing high-quality, safe, and reliable diagnostic products that meet European regulatory standards. Moreover, CE marking shows manufacturers typically undergo testing, quality control, and documentation of the organization’s compliance with EU directives.
