Hi Ronen,
Thanks for prompt reply. Can you believe it we had no issues preparing documents for
510K but unable to figure out what they mean by following:
A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on
the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities
required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should
include:
i) A statement signed by the individual responsible, that, as required by the risk
analysis, all verification and validation activities were performed by the designated
individual(s) and the results demonstrated that the predetermined acceptance criteria
were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in
conformance with design control procedure requirements as specified in 21 CFR
820.30 and the records are available for review.
IS FDA looking for "I agree" statements here or are they looking for detailed analysis.
Any example template or example documents will be really appreciated.