Accreditations & Compliance

Partnership

Science Team is the exclusive authorised distributor of Advanced Instruments (now merged with Nova Biomedical) in Singapore, the leading U.S. manufacturer of high-precision instruments, trusted by laboratories worldwide.

Our list of certifications and accreditations provide a foundation that aligns with GMP expectations and supports regulatory compliance.

Our team is qualified and certified by the manufacturer, Advanced Instruments, to perform Installation Qualification and Operational Qualification (IQ/OQ) services if your laboratory requires.

Advanced Instruments products are variously registered or compliant with applicable regulatory authorities in various international markets (e.g. U.S. FDA, EU IVDR, Health Canada), depending on model and intended use.

Further information can be found on manufacturer's website.

Advanced Instruments is certified under the Medical Device Single Audit Program, complying with requirements from the Australia TGA, Brazil ANVISA, Health Canada, Japan MHLW, and the US FDA.

Our products are manufactured under ISO (International Organisation for Standardisation) quality standards. Reflecting internationally recognised standards for quality assurance and medical device manufacturing.

The relevant certifications are:

  • ISO 9001 — Quality management system.

  • ISO 13485 — Quality management system standard for medical device manufacturing.

  • ISO 17034 — Competence for production of reference materials. 

ISO Certified

Data integrity certification 

Our osmometers meet current regulations and restrictions, providing secure, accurate and fully traceable data to support your laboratory’s compliance.

Built-in data integrity features support compliance with U.S. FDA 21 CFR Part 11, ensuring secure and traceable electronic records for laboratories.

Osmometers are designed with features that support compliance with EU GMP Annex 11 (EudraLex Volume 4) — which sets out requirements for computerised systems used in GMP-regulated activities for medicinal products in Europe.