There are many routes open to achieving a CE mark for a medical device. Factors that influence the route include the classification of the device, the costs involved in clinical investigation or clinical evaluation and the intended use of the device.
QCS can assist in the development of trials, programmes and activities that are required to meet CE Certification requirements as required by the European medical devices directive.
This includes advice on ISO 13485 (and determining if compliance is a requirement) and encompasses the necessary aspects of Management Responsibility, Resource Management, Product Realisation and Measurement, analysis and improvement. Recent changes in the standard ensure that any requirements not applicable to the organisation can be excluded from the scope of their ISO 13485 certification, allowing the standard to be applied more easily to organisations.
We also provide product specific support in relation to preparation of technical files, design and development files and post market surveillance plans to meet statutory vigilance requirements.
We have consultants with experience in all phases of the product development life-cycle, so whether you intend to CE mark a new product or are continually improving your existing products to keep up with ever more stringent regulatory requirements, QCS can provide the expertise you require in:
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