Quality management system
The majority of device manufacturers must implement a Quality Management System to satisfy the country where they market their product. For example, European regulations encourage and many Notified and other Conformity Assesment Bodies insist that medical devices (EC Product Class IIa – III and in vitro diagnostic devices) must apply a formal quality system such as the Harmonised standard EN ISO 13485. EN ISO 13485 supplements ISO 9001, with further requirements in elements such as process control, design control, retention of records, traceability etc.
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 the particular market. QFI has helped organisations gain access to specific regulatory domains regardless of location through:
- Creation and implementation of Quality Management Systems (QMS) satisfying Council Directive 93/42/EEC, EN ISO 13485 and EN ISO 9001. Regularly completed in less than three months, often include comprehensive technical documentation for all device classes, preparation and submission of documents to the Competent Authorities, and fine tuning of the Quality Management System
- Creation and implementation of 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 Quality Management Systems (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 have also produced QMS to enable checks to fulfill a variety of other countries, including: Brazil, Mexico, Middle- and Far-East, etc.
QFI only implements original, custom-written Quality Management Systems. We do not re-use templates. 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 Notified Body and other audits or Competent Authority 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. Further, our clients determine the degree of assistance necessary from a simple review of documentation to complete preparation and implementation undertaken entirely by QFI Technical Specialists.
Although we customise our solutions for every client, our Quality Management Systems comply with the following:
- EN ISO 13485
- FDA Good Manufacturing Practice (GMP)
- Canadian Medical Devices Regulations
Further, every Quality Management System prepared by Quality First International has passed EN ISO 13485 audit first time, fulfilling all European, US, Australian and Canadian and other requirements.