QRC Solutions - Quality Assurance

Medical / Business Writing

Useful Links

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.