I would really appreciate any advice on the following.
One of the key requirements of the new regulations is that the manufacture of a medical devices occurs under an appropriate quality management system (e.g. 13485).
Many hospitals manufacturer either custom devices, or devices used only in-house (therefore applying the Health Institution Exemption). However, it is likely that only part of the hospital will be registered to a suitable quality management system.
What is the specific meaning of the phrase “under an appropriate quality management system”?
Can a hospital department which is registered under a quality management system (e.g. Medical Physics), act on behalf of another department which is not registered under a quality management system (e.g. Ophthalmology) for the purpose of manufacturing devices for the non-registered department?
One of the key requirements of the new regulations is that the manufacture of a medical devices occurs under an appropriate quality management system (e.g. 13485).
Many hospitals manufacturer either custom devices, or devices used only in-house (therefore applying the Health Institution Exemption). However, it is likely that only part of the hospital will be registered to a suitable quality management system.
What is the specific meaning of the phrase “under an appropriate quality management system”?
Can a hospital department which is registered under a quality management system (e.g. Medical Physics), act on behalf of another department which is not registered under a quality management system (e.g. Ophthalmology) for the purpose of manufacturing devices for the non-registered department?