AUDIT SERVICES REVIEW OF QUALITY SYSTEMS

Manufacturers are required to review their quality systems, to ensure compliance of regulations and international standards.

You are in good hands, since we provide audit services for a wide range of Standards:

• ISO 13485
• Canadian Medical Device Conformity Assessment System (CMDCAS)
• EE EU Directive 93/42/EEC
• US Food & Drug Asminstration 21 CFR Part 820 (QSR-21 CFR) (Part 820)
• Good Sales Practices for Medical Devices (GDPMD)
• Japanese Pharmaceutical Affairs Act (JPAL) Med Devices Regulations
• 2012 Malaysian Medical Device Regulations
• Australian Drug Administration (TGA)

. . .  Providing audits for: gap analysis, internal and pre-audit services.

We also offer 'supplier audits' to ensure that relevant compliance is met.