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If you manufacture medical devices of any kind, then you need to be certified as a medical device manufacturer to be able to sell your products in the EC. You will also need this certification to enable you to move into overseas markets such as the USA, Canada, Australasia and beyond.
Before even attempting to prepare an ISO 13485 quality manual for medical devices, you need to consider many aspects of your business and product or service, before putting pen to paper, which eat up the human resource of at least one or two of your management team for a prolonged period of time.
Apart from the serious personal commitment required to achieve this documentation to the level required for ISO13485:2003 certification, your time and therefore your skills and experience, which you should be using to push your business forward is used up in preparing documentation. In most cases, business people do not even know where to begin. After all, you are a manufacturer or sales orientated professional, not a Quality Management System expert!
ACS can prepare your quality manual to facilitate meeting ISO 13485:2003 requirements at a very reasonable price. It will include all required procedures, forms and checklists designed specifically for your needs.
For more information and an obligation-free chat, please send a brief note of your requirement to info@archer-consulting.co.uk when we will give you a realistic idea of likely costs and time-frames. Bear in mind that our quotations mean just that - we do not give prices to secure assignments - our experience guarantees yours. | 
