Dear All,Need your advice on non-applicability of clauses and subclauses (6, 7& 8) from ISO 13485; for the Scope: "Design and development of sterile XYZ device from BioMaterial"We (Consultant and In-House Design and QA Team) are quite confused and arguing internally about the non-applicability of the ISO 13485 clauses and sub-clauses for the above scope.It would be very helpful if you could clarify that the clauses and sub-clauses (6,7&8) can not be applicable to the above-mentioned scope.
P.S.: As of now, we only want to obtain ISO 13485 certification for design and development of the device.
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Navnath Kadam Pharm, MBA
India
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