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Medical Devices Directive (MDD)
Quality Management System

All dental laboratories, no matter how small, have always included a degree of quality management in their manufacturing procedures. However, with the advent of the Medical Devices Directive (MDD), quality control has now become a mandatory requirement. Unlike DAMAS or ISO 9000 certification, which is purely voluntary, MDD has been law since 13th June 1998 and must be adhered to. The Medical Devices Agency controls this Directive in the UK.
 

In early 1997, StingRay recognised that dental laboratory owners were unsure of this new law. Consequently, they set out to research and develop a Quality Management System (QMS) specifically aimed at dental laboratories and which meets the requirements of MDD.

After careful research made in conjunction with dental technology professionals, the StingRay MDD Quality Management System was put on sale in 1998 and is now being used by dental laboratories throughout the UK. Without any shadow of doubt the publication succeeds in taking the fear out of MDD. With its Quality Manual and Work Instructions it enables both existing and new dental laboratories to easily meet the requirements of MDD.
 
What is the StingRay MDD Quality Management System?
  • A purpose made MDD compliant Quality Management System for the dental technology profession.
  • Easy to implement with the minimum of aggravation.
  • A system supplied with a fully detailed User Manual. There are no costly seminars to attend.
  • Ideal for any size of laboratory.
  • Being a paper system, it does not rely on expensive computers or proprietary software.
  • The entire system is also supplied on disk for those who want to customise it to suite their own purposes.
  • Can be used in conjunction with your existing quality systems to ensure full compliance to MDD.
  • Can be used as a stepping stone to ISO 9000.
 
The StingRay MDD Quality Management System contains:

A Brief Guide to MDD - Detailing the legal requirements of MDD and what it aims to achieve. For those people who know little or nothing about MDD, this short guide explains in simple, jargon free, terms the parts of the Directive that affect the dental technology profession.

The MDD Quality Manual - A loose-leaf file containing a complete purpose-designed QMS, comprising:

  • Quality Policies setting out how your management will control the quality issues demanded by MDD.
  • Work Instruction templates for compiling the manufacturing procedures used in a laboratory. Usually this is the only part that requires some input from the purchaser of the system. However, examples are provided showing how to compile Work Instructions.
  • Forms needed to run the system, including the all-important Laboratory Job Sheet, which is central to the entire system.

Plus

MDD on floppy disk.Floppy Disk. A disk containing the Quality Manual so that you can customise it to your own requirements.


The User Manual - Detailed instructions showing you how to set up and use the QMS are provided within this publication. It is this document which makes the entire system so user friendly and avoids having to attend costly seminars to learn how to use it. The User Manual contains guidance on all the policies and procedures and also includes flow diagrams that take you easily through the implementation and use of each one.
 
What Does it Cost?

The entire package, which includes a free telephone advice line, is available for only £375.00

For a free information pack please visit our enquiries page and complete the form provided.

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