We assist our clients to establish, integrate, implement and maintain a quality management system that complies with the specific international/regional/national standards and applicable regulatory requirements where the product is sold. It includes:

Medical Devices

  • ISO 13485:2016 Medical Device QMS Requirements
  • Malaysian ACT 737 and it's subsidiary regulations
  • Good Distribution Practice for Medical Device (GDPMD)
  • Regulation (EU) 2017/745 on CE Marking of Medical Devices
  • U.S. 21CFR Part 820 QSR and FDA's Regulations
  • MDSAP (Medical Device Single Audit Program)
  • Integration of ISO 13485:2016 with other standards and country-specific regulatory requirements

Cosmetic & Personal Care

  • ISO 22716:2007 Cosmetics Good Manufacturing Practices (GMP)
  • NPRA's Guideline on Good Manufacturing Practice (GMP) for Cosmetic


  • ISO 9001:2015 QMS Requirements
  • Sector-specific management system standards

We also provide post-certification support for internal audits, ongoing compliance, and maintenance of quality and regulatory compliance management system.