Compliance with Essential Requirements of Medical Device Directives can appear daunting, particularly for Start Up companies. It mandates that before the product can be CE marked and sold that there is a Quality Management System operating in the organisation. However Quality Management is often perceived as an imposition, a yoke stifling the creativity in the early stages of development. Alternatively it can be seen as an additional burden slowing the development process and increasing costs. As a result the early stages of development, when the organisation is fired by enthusiasm for its technology, compliance with the requirements of the Medical Device Directive can appear to be less urgent than the myriad technical and business issues that must also be addressed. As a result it can be seen as something that is to be done in the future, by the time the organistion comes to consider CE marking the product. However if the Quality Management System is considered as an after thought then this can make the development of the technical documentation required to support CE marking the product difficult since some aspects of the development may not have been demonstrated to be robust. But if the Quality Management System is developed in tandem with the developing technology, then the critical aspects of the product can be developed with the required tractability and robustness as experimental science is honed to routine. This will ease the creation of the technical documentation required to support the product.
To encourage the early implementation of a Quality Management System, it is useful to remember that the various standards are developed to both enable compliance with the quality management requirements of the Medical Device Directives and also to reflect current best practice. Early and considered implementation of compliant business processes can improve efficiency and ensure compliance with the Directives.
Why Kershaw Technology Services?
Kershaw Technology Services has been created to support the development of medical devices. The people within the company have many years experience of medical device product development form both a technical/ scientific perspective and from a quality management and regulatory perspective. This combination provides for the development of systems, which meet the quality and regulatory requirements while controlling the impact on the product development process.