Services

Openwater QA-RA Systems can write Quality Management processes to ISO 13485 that will meet not only the standard requirements but those of the company concerned as well. These systems are written around the organisation’s existing processes and practices, as far as is possible, and will embed seamlessly into the workings of the company. Liz’s personalized training and support ensures the systems become second nature to all staff and top management alike.

The advent of the Medical Devices Regulation presents a new challenge with many changes which Liz is well placed to assist with. She integrates this regulation into quality management systems and advises and assists with the updating of the Technical documentation. 

With a background in manufacturing, Liz provides extensive specialist knowledge and advice based on her experience with quality control requirements, testing and special process operations, such as clean room manufacture. She also strives to be always up to date with all current legislation.

All specialisms can be provided on a project basis and end only once the systems are fully up and running. Where clients are small businesses, or businesses of any size who would like some extra assistance, Liz continues to offer support on a mutually agreed time basis.