The plan for designing and developing the medical device under design controls: phases, reviews, verification and validation, responsibilities, interfaces and deliverables.
Plan Work product in the Medical electronics and medical device chips lifecycle
Design controls under ISO 13485 and 21 CFR Part 820 require a plan that is followed and kept current. It organises chip, board, software and device work into one controlled programme; without it, reviews are skipped, deliverables are missing at submission and the quality system fails audit.
The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.