8 Steps towards Conformity
8 steps to declare the conformity of your works:
- The laboratory receives from the dentist the impressions with a prescription of a customed medical dentistry device. First of all we've to insert the datas of the prescription in the program. In this way ORISLAB® will use the information inserted to automatically prepare the whole necessary documentation. For datas filling in the program we can choose among many forms (Office, associations, free) for the "medical prescription". The forms can be also free printed and given to the doctor to be filled. On the medical prescription they will have to appear all the important information that make the technician realizing a safe custom medical device for users (patients)...
... ORISLAB® prints the Prescription form for the doctor ... - After an analysis of the prescription and appraising the impressions, the technician decides to adopt the technical solutions to realize the prosthesis. The solutions must be underlined in the executive technical project joined with possible decisions to obviate to technical drawbacks found during the analysis. ORISLAB® will create the technical project thanks to the datas inserted in the prescription...
... ORISLAB® automatically prints the TECHNICAL PROJECT OF EXECUTION... - This step underlines the evolution introduced by the 93/42/EEC directive in subject of "custom medical devices". The laboratory won't have to twist its own operational procedures, since the successes gotten till today witness the validity of it, but it has to change the way of checking and to document what realized. Aims of the 93/42 directive are, besides, the elimination of the risks for users tighten to prosthesis or "custom medical devices". Referring to prescription datas and to the transmitted material (impressions, relieves, etc.), the technician can do a preliminary analysis of the risks, that will be subsequently useful to plan the work in order to eliminate them. ORISLAB® brings a list of the possible risks during the realization of the different typologies of prosthesis. To the list of the risks is possible to add datas about the biocompatibility or toxicity of the materials used...
- Other very important step to reach the purposes preset by EEC's 93/42 Directive is the control and the documentation of working progresses. This means to manage with coherence all the rings of the chain involved in the manufacture of the customed dentistry medical devices. To reach this purpose ORISLAB® furnishes many protocols of example for the various types of prosthetic works. These are composed by a succession work phases, by the relative controls during all phases and by the relative risks to be considered and to erase. In such way it will be possible for the laboratory to give the correct evidence to the controls and the evaluation of the risks in conformity to the ESSR (essential safety and health requirements) fixed by the enclosure 1 of the 93/42/EEC Directive. The technician can mark the actions of the effected controls, annotating possible problems found during the phase of manufacture of the medical device......
ORISLAB® prints the Technical Card that accompanies the MANUFACTURE of the device... - The verification is useful to the technician to check that the gotten results correspond to the aim and to the initial content resulting from the medical prescription. In this phase ORISLAB® will underline possible controls not well ended or not removed risks, giving to the technician the possibility to intervene in order to correct them. Other important aspect of the verification phase is the batches management of the used materials; ORISLAB® automatically recovers the numbers of the batches of the first subjects used in the custom medical device acquiring datas from the purchased materials avoiding to the technician a hard-working assignment of research...
- The phase of labeling is important in order to identificate the customed medical device and its user once same device reaches the dental surgery. The labeling, the packaging and the delivery are expressly declared in the EEC's 93/42 Directive. The label is automatically produced by ORISLAB® without doing any operation. The label can however be personalized and/or equipped by comments and notes (ex.: not sterile product, etc.)...
... ORISLAB® automatically prints the Label for work deliveries... - Another obligation given by the EEC's 93/42 Directive is to equip the customed medical device with user's guide, instructions for installation, maintenance and control. This documentation, even if in a first moment it could seem unimportant, it has great importance instead. With the user's guide it's necessary to identify which the correct destination of the prosthesic customed medical device produced in the laboratory is. You have also to point out the necessary instructions for prosthesis use as well as its maintenance and possible controls to be applied while using. ORISLAB® brings a bookstore of "texts type" that can be taken as a sample or integrated with new instructions and instructions from all laboratories. The documentation for this step is automatically printed by Orislab® in a way that is simple, organized and fast...
... ORISLAB® prints the necessary documentation and the declaration of conformity... - The correct results gotten in the 7 preceding steps, allow to immediately have ready the special Declaration of Conformity of the customed medical device realized. The Declaration of Conformity must be signed by the technician. It's necessary to brought on it the manufacturer's datas , the data of whom prescribed the customed medical device and the user's one. Together with the Declaration of Conformity printings, Orislab® brings the possible not removed or residual risks, the instructions of use, the maintenance and the controls. ORISLAB® allows to choose among many types of printings for the Declaration of Conformity (as for instance ours imitated printing to Book). you can Now introduce on the market your medical device...
... ORISLAB® prints the Declaration Of Conformity...
We have reached the Declaration of Conformity in 8 steps as required by the EEC's 93/42 Directive.
All the documents that ORISLAB® has printed, will form the TECHNICAL BROCHURE
of the customed medical device you worked out.
This documentation will have to be preserved for the period
required by the EEC's 93/42 Directive.
The potentialities of ORISLAB® will guarantee to complete in SECURE way
the Declaration of Conformity and to QUICKLY reproduce it
for the same kind of device without having to repeat all the 8 steps.
COMPOSITION OF THE TECHNICAL BROCHURE:
Prescription - Technical Project of execution - Technique Card (Manufacture)
User's guide (Documentation) - Declaration of Conformity!
