Quality Management Systems

They’re called Quality Management Systems for a reason. Quality systems are all about management – providing the rigour and discipline to drive product quality to meet your customers’ needs and providing the information that is the lifeblood of management effectiveness.

A well executed system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement. Your employees and partners will understand their role in the Quality System and the value they add to it through compliance.

Marketing worldwide?

Then you will need to meet requirements in multiple markets. Let us show you how you can build one Quality System that is compliant to both ISO 13485 and the US FDA 21CFR 820 “Quality System Regulations”. We can also advise on more specialist GxP requirements, including ISO 17025 GLP and specialist quality systems for clinical laboratories and for R&D facilities or design houses.

We can help you with

  • Implementation or upgrade of systems to compliance with:
    • GMP ISO 13485, FDA 21 CFR 820
    • GLP ISO 17025, FDA 21 CFR 58
  • Assistance with facility inspections including internal pre-audit and attendance at external audit.
  • Process development and implementation for distributors including
    • Postmarket systems for adverse event reporting
    • Good Distribution Practices (GDP)
    • Advertising compliance
    • Recalls management.

Email [email protected] or call +61 2 9906 2984.

Need assistance with your Global Medical Device and IVD Regulatory Services?

We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.  Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

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