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hg93 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls 8 years, 4 months ago
Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks:
Identification of the regulatory pathway based upon the device risk classification and applicable harmonized standards.
Development of a risk management plan
Approval of your design plan (1st design review)
Initial hazard identification
Documentation and approval of design inputs (2nd design review)
Risk control option analysis
Reiterative development of the product design
Risk analysis
Documentation and approval of design outputs (3rd design review)
Design verification and validation, and risk control verification
Clinical evaluation and risk/benefit analysis
Development of post-market surveillance plans with post-market risk management plan
Development of a draft Device Master Record(DMR) /TF Index
Commercial release (4th and final design review)
Regulatory approval and closure of the Design History File (DHF
Review lessons learned and initiate actions to improve the design process