Dear all
Request a help from experts.
A company which is involved only in Design and Development of Medical devices for its clients, do not perform Manufacturing, do they have to comply to 7.4 Purchasing for components to be purchased for D&D activity?
I am of the opinion, it is not necessary as D&D is a Research activity and may have to purchase all kinds of parts from different sources for "trial" purpose and practiccally following the 7.4.1 and 7.4.2 will be impractical.
Moreover the Standard under 7.3 does not mention the requirement. However 7.4 mentions as "organisation" in which case it may be applicable.
Additionally can such an organisation can declare 7.4 as non-applicable?
Regards
Sriram
Request a help from experts.
A company which is involved only in Design and Development of Medical devices for its clients, do not perform Manufacturing, do they have to comply to 7.4 Purchasing for components to be purchased for D&D activity?
I am of the opinion, it is not necessary as D&D is a Research activity and may have to purchase all kinds of parts from different sources for "trial" purpose and practiccally following the 7.4.1 and 7.4.2 will be impractical.
Moreover the Standard under 7.3 does not mention the requirement. However 7.4 mentions as "organisation" in which case it may be applicable.
Additionally can such an organisation can declare 7.4 as non-applicable?
Regards
Sriram