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Quality Assurance

Many companies, such as medical device and pharmaceutical manufacturers, require a certified Quality Management System prior to obtaining regulaory clearance to market their products.

 

Other companies prefer to operate under a Quality Management System to take advantage of the cost savings and efficiencies that such a system offers.

 

QRC Solutions has experience in establishing Quality Management Systems compliant with a range of international standards, including:

  • ISO 9001:2000, Quality Management Systems Requirements;
  • ISO 13485:2003, Medical Devices Quality Management Systems Requirements for Regulatory Purposes;
  • ISO 17025:1999, General requirements for the competence of testing and calibration laboratories;
  • ISO 15189:2003, Medical laboratories Particular requirements for quality and competence;
  • ISO 14001:2004, Environmental management systems - Requirements with guidance for use;
  • TGA’s Australian code of good manufacturing practice – human blood and tissue;
  • FDA’s Quality System Regulations (QSR);
  • FDA’s Good Laboratory Practice (GLP);
  • Health Canada’s Medical Device Regulations; and
  • OECD Good Laboratory Practice (GLP).

Where We Can Help You

 

We can also assist you in:

  • Establishing policies, procedures, manuals, technical files, design dossiers and Design History Files.
  • Conducting risk assessments.
  • Conducting gap analyses and internal audits.
  • Liaison with third party certification bodies such as the TGA, FDA and Notified Bodies.
  • Process and product validation.
  • Software validation.
  • Internal quality systems auditing

Our Experience

Our quality assurance expertise has assisted companies working in the areas of:

  • sterile, surgically implantable medical devicesclass I devices;
  • software-driven medical devices;
  • blood and tissue products;
  • biologics;
  • biofuels manufacturing; and
  • drug development.