1. when the customer provides the specification ( or reference dimensions), and rest of the activities ( from fabrication/design of moulds/change parts are taken up by manufacturer), can the manufacturer claim the exclusion of 'design and development' for the 13485 requirements.
2. when the manufacturer has an sister concern which deals with fabrication & design, can the manufacturer still claim the exclusion of 'design and development' for the 13485 requirement.
my contention is that, manufacturer needs to comply to the requirement; either by calling out the either the scope of activities or establishing the dependence/traceability to the syster concern.
lets say, I am talking about syringe, which, individually constitutes as primary packaging material,; but when assembled with stopper-plunger and supplied as "ready to use or ready to fill", would constitute an 'device'; Now the question is, whether the manufacturer can claim exclusion of 'design and development'.
2. when the manufacturer has an sister concern which deals with fabrication & design, can the manufacturer still claim the exclusion of 'design and development' for the 13485 requirement.
my contention is that, manufacturer needs to comply to the requirement; either by calling out the either the scope of activities or establishing the dependence/traceability to the syster concern.
lets say, I am talking about syringe, which, individually constitutes as primary packaging material,; but when assembled with stopper-plunger and supplied as "ready to use or ready to fill", would constitute an 'device'; Now the question is, whether the manufacturer can claim exclusion of 'design and development'.