Supplier Management Key elements & Guidance

A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]

V & V Documentation Model – 11 Documents

There are 11 document types in the basic V&V Documentation model as per “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, Table 3, May 11, 2005: LOC (Level of Concern: Min, Mod, Maj) SW Description Hazard / Risk Analysis (ISO 14971 / ICH Q9 = recommended       model; ultimately Read more about V & V Documentation Model – 11 Documents[…]