In an effort to provide a complete and specific answer to our partners, we may manufacture in a customised manner the special surgical instruments they wish to implement, redo them according to the model or adjust them.
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Customized manufacture
We meet the project owners (Surgeons, instrumentalists…) to understand their needs. After analysing the existing offer, we implement specifications defining the outlines of the project.
We detail here the project: area, use of the instrument, aim, comparison to existing solutions, project owner’s wishes.
If necessary and based on the specifications, we draw the instrument by means of CAO software (computer-assisted construction) in 3D. This second stage enables us to fuel a new discussion with the project owner and to refine the need.
It is often useful to make a prototype in order to confirm the overall project, this allows considering in concrete terms what the requested surgical instrument shall be.
We proceed to the manufacture of an operational test piece such as the instrument after validation or we use the so-called additive technology (3D printer) with a view to providing the end user with an idea with respect to what the instrument could be. In order to do this, we use polyamide that may be sterilised which allows the introduction of the prototype into the operation room after a prior sterilisation and its comparison with the reality on the ground.
Then we choose the manufacturing workshop that is the most suitable for the project (sometimes starting with the previous stage if an operational prototype was already manufactured). We have a network of partners manufacturing workshops specialising in the surgical instrument, each one with its own specialities, particularities, materials, preferred disciplines…
It is impossible to suggest a surgical instrument to a European hospital institution if it lacks the EC marking. This compulsory marking certifies that the manufacture of the surgical instrument followed during all the stages the recommendation of the European Medical Devices Directive 93/42 and in Belgium the Royal Decree of 18 March 1999. MD Medical affixes the EC marking after having implemented the technical file of the instrument and proceeded to its notification to FAMHP (Federal Agency for Medicinal and Health Products). We rely on our ISO 13485 certified quality assurance system for drawing up documents to supply such as the EC Declaration of Conformity.
MD Medical solely manufactures First Class surgical instruments such as the ones defined by the abovementioned Directive.