Quality Management System (QMS) is a set of policies, processes, and procedures that a manufacturer must have in place to ensure that their products are safe and effective for their intended use. The QMS includes all aspects of design and development, manufacturing, product labeling, supplier management, clinical data, risk management, storage, complaint handling, distribution and more.

With our technical expertise, accuracy and confidentiality we have helped a wide range of companies devise and implement Quality Management Systems that satisfy US FDA, EU regulations, TGA Australia, Health Canada and other international regulations to allow legal placement of a product on a particular market.

QFI provides 3 different solutions: 

• Creation and Implementation of EN ISO 13485 and EN ISO 9001. (Regularly completed in less than three months, and includes comprehensive technical documentation for all device classes, preparation and submission of documents to the Competent Authorities, and fine tuning of the QMS)
• Creation and implementation of QMS satisfying the U.S. Code of Federal Regulation – Title 21 (21 CFR) Quality Management Systems (QMS) required for US FDA clearance. (QFI regularly prepares and submits US FDA 510(k) and Premarket Approval (PMA) submissions on behalf of clients worldwide)
• Creation and implementation of hybrid (QMS) designed for dual- or multiple jurisdictions, eg simultaneous satisfaction of US FDA, and European Community regulations allowing the client to achieve FDA clearance and legal market placement in the European Community within time and budgetary constraints.

We can cover a variety of other countries as well, including: Brazil, Mexico, Middle- and Far-East, etc.

QFI prepares custom-written Quality Management Systems. All procedures and record formats are prepared specifically for each organisation using only direct observation of client practice and applicable standards as input. QFI provides skilled guidance and direct assistance to clients during submissions to Notified Bodies and other audits or Competent Authorities and US FDA inspections. We have an exemplary record in this capacity. To date, no QFI-implemented Quality Management System has ever failed initial assessment or given rise to a non-compliance report (483 under US FDA 21 CFR) culminating in decline of registration or approval.