Medical devices custom-made

A new device that is specifically made in accordance with a duly qualified medical practitioner s written prescription and which gives, under the practitioner s responsibility, specific design characteristics, and is intended for the sole use of a particular patient is permitted to be marketed without CE marking imder provisions referring to custom-made devices. The prescription may be made by any person authorised by virtue of their professional qualifications to do so. Mass produced devices that need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices. 

A non-EEA manufacturer may place a Class I or custom-made medical device or a system or procedure pack on the EU market under their... 

The second edition CD-ROM contains 139 validation SOPs they are made available so that customers can input them into their computers and use their Microsoft Word programs to edit and print these documents. The contents of the procedures are written in simple and precise language to be in compliance with FDA regulation GMP and GLP requirements. The book ensures minimization of the number of documents to avoid the nightmare of the head of quality assurance at the time of FDA audit. The SOPs exclusively refer to the documents specially required for compliance however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. 

On the right-hand side of the belt the hook-and-loop fastener is inserted to close the medical back belt. Velcro closures are frequently used in orthopaedic devices because they can be employed very easily. Most of the orthopaedic devices have to be custom-made because they have to ht very precisely. With a Velcro closure the medical back belt can be closed individually, and only general sizes like s, m, 1, xl and xxl have to be produced. The whole construction of the outer and inner surface is shown in Fig. 6.4. 

All medical devices are required to cany a CE marking unless they come within the definitions of custom-made devices or devices intended for cUnical investigation . 

Hot Plate Welding provides the ability to weld medical devices whose joint areas are non-uniform nor linear (See Figure 2). Part size is not a critical issue allowing parts as large as 30.5cm x 30.5cm to be successfully welded. Custom made equipment can expand the size of parts to be assembled. 

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