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Quality Systems

If you are manufacturing medical devices in the higher risk categories under EU or US legislation, then it is almost certain that the company will need to have a quality management system meeting the specific requirements of one or more regulatory jurisdictions.


In Europe, what is known as the ‘Full Quality Assurance System’ in the current Directives and future Regulations is broadly equivalent to EN ISO 13485, ‘Medical devices, Quality management systems, Requirements for regulatory purposes’, with the addition of certain administrative requirements. For the US, the quality system requirements are documented in 21 CFR 820, otherwise known as the Quality System Regulation (QSR). While there is a great deal of commonality between the ISO standard and the QSR, there are some significant differences in both content and interpretations, which need to be understood if compliance with both CE marking and FDA is required.

Many manufacturers are already in the process of updating their quality systems to match ISO 13485:2016, but some companies may need external help in understanding the differences from the previous version and their implementation into the company’s system. Donawa Lifescience Consulting (DLC) can help in this respect, by assisting the company in revising its Standard Operating Procedures (SOPs) and carrying out internal training.


Companies that are already certificated for European purposes may need external support when entering the US market, in order to integrate the QSR requirements into their existing systems. DLC offers both a gap analysis and a full mock FDA inspection approach to identifying and resolving any discrepances from QSR requirements. In addition, should an FDA inspection be scheduled for your facility, DLC can carry out a pre-audit, and assist in both pre-inspection and post-inspection corrective actions.

DLC also has extensive experience in attending FDA inspections with clients, to ensure no major interpretational issues arise. How companies respond to any Form 483s issued by the investigator is very important in helping to prevent a Warning Letter being sent from FDA, which may include an import hold on all products manufactured at that facility. DLC has helped many clients respond correctly to Form 483s, by putting in place realistic and comprehensive corrective action plans, to ensure as far as possible that the company’s products can continue to be exported to the US. Should a Warning Letter be issued, DLC can also help companies respond in such a way as to minimise the timescale for the FDA file to be closed.


DLC can also help in the establishment of a new quality system, meeting the requirements for CE marking, the QSR, or both, laying the foundations for long-term quality system compliance and viability. Once established, a company’s quality system involves all parts of the business. As such, ongoing success depends upon proper quality system design, documentation, implementation, maintenance and ongoing development. In a well-managed QMS, the ‘quality culture’ should drive all aspects of the business, with the aim of achieving long term success.

In addition to helping with the initial QMS implementation, DLC can assist with ‘fine tuning’ your processes and metrics to keep pace with company expansion, including entering new markets with different regulatory requirements, or the manufacture of products falling under higher risk classifications.

To discuss the DLC quality system services, please contact us to see how we may be able to assist.