Quality & Regulatory Compliance
Certifications & Accreditations
ISO 9001:2015 – Quality Management System
Scope:
Design, development, manufacturing, distribution, and technical support of molecular biology products (including nucleic acid purification kits, PCR/qPCR reagents, enzymes, and related instrumentation), microbiology products (including microbial culture media, specimen collection and transport systems, and diagnostic reagents), and cell culture products (including cell culture media, sera, and supplements).
ISO 13485:2016 – Medical Device Quality Management System
Scope:
Design, manufacturing, and distribution of in-vitro diagnostic (IVD) medical devices, including microbiology specimen collection and transport systems, molecular diagnostic kits, reagents, diagnostic instruments and equipment, cell culture media, sera, and related accessories intended for diagnostic or clinical laboratory applications.
ISO 14001:2015 – Environmental Management System
Scope:
Implementation of environmentally sustainable practices in the design, manufacturing, packaging, and distribution of molecular biology reagents and instrumentation, microbiology culture media and diagnostic products, and cell culture media and sera, promoting resource efficiency and reduced environmental impact.
Rigorous Testing Protocols
Avam products undergo rigorous testing to guarantee consistency, purity, and efficacy:
Purity Assessments: Employing advanced analytical techniques (HPLC, GC, spectroscopic analysis, microbial testing) to ensure products are contaminant-free.
Efficacy Testing: Utilizing functional assays, stability tests, and real-world performance evaluations to validate product reliability.
Batch Consistency Checks: Comprehensive in-process quality controls and final product validations ensure each batch meets strict specifications.