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Documentation & Control
Pivotal’s expertise in producing detailed and well-mapped documentation related to product development helps companies quickly meet the requirements of medical device development.
We start with the Deliverables List that is based on the ISO 13485 clauses for development. It identifies every item that is required for completion of the product such as plans, requirements, design, verification and more. It continues to be a living document that ultimately is the table of contents for the Design History File (DHF) and the Device Master Record (DMR). Expectation of what the client will receive are set in the Deliverables List, along with clear identification of responsibilities.
