International Laboratory Directories

Standards / Methodologies:

-GAP Analysis audits: Define your current level of compliance with the appropriate quality regulations including FDA QSR , FDA GMP, ISO 13485, Japan PAL , PICs standards and Canadian Standards CMDR.

-ISO 13485 audits

-GMP audit: Identifies any non-compliances to FDA 21 CFR 211 regulatory requirements.

-Quality System audit : We perform this audit for medical device companies to identify any non-compliances to FDA QSR -21 CFR 820 regulatory requirements.

-Japanese Accreditation Audit : We perform this in compliance with PAL to help you prepare for the Japanese accreditation audit.

Full or Partial internal audits : ISO and FDA QSR (21 CFR Part 820) require that manufacturers conduct regulatory internal audits of their quality management systems. We can perform internal quality audits for you to allow you to have an independent review of your full quality system. We can either conduct partial audits where we can focus on specific areas of the quality system where you suspect non compliances occur or have occurred, or focus on areas where audits cannot be conducted by your in-house internal auditor due to possible conflict of interest.