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9th December 2008

Not just a standard operating procedure

• Cambridge Consultants launches innovative Medical Development Process, fully registered to the ISO13485 quality standard

Cambridge Consultants has created a breakthrough system to seamlessly manage the design and development of medical devices, providing clients with a faster and cheaper route to market.  Fully registered to the ISO13485 standard in Europe and the United States, the Medical Development Process (MDP) is an in-house project management system that ensures regulatory compliance and best practice in the development of medical devices from concept through prototyping to manufacture.

Based on DocMan, the company's own tried and tested document management system, MDP is an intelligent knowledge-based structured development system, designed to automate some of the routine processes involved in complex medical product design, but avoid the box-ticking approach encouraged by some regulatory requirements.  It uses the ISO13485 standard as its base, but goes beyond the expectations of this standard alone, incorporating the combined experience and knowledge of Cambridge Consultants' medical technologists - a team with a track record of more than 30 years in medical device design.

"MDP is quite unique", explains Duncan Bishop, Medical Programme Director at Cambridge Consultants and architect of the new system.  "Our designers, engineers and scientists - some of whom have many years of experience, and some of whom are new to the field - are finding that this process not only simplifies the administration and management of their work, but that it can also learn from them as they take a project from conceptual design through to small batch manufacture for initial sales.  Each new project we work on is different to the legacy of past and existing projects, and so the system might not have ‘seen’ a particular requirement before.  It’s capacity to learn and 'digest' infinite new project eccentricities - all within the constraints of the relevant regulatory frameworks, yet without encouraging ‘deliverable document syndrome’ - is something our teams, and indeed our clients, value very highly."

The implementation of the Medical Development Process at Cambridge Consultants means that each new development is less prone to critical path error, and can therefore be completed in less time and at less cost than with a more conventional project management system.  Furthermore, because the company's technical staff are freed up from some of the more routine administrative and management work involved in all projects, they will have more time to dedicate to innovative thinking, adding the real value that their clients expect from them.

Cambridge Consultants has now embedded the MDP system in all medical technology developments, including drug delivery, diagnostics and surgical projects in both its UK and US offices.

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