Validation and verification as stated in the lectures are both independent procedures used to establish that the product meets specifications/requirements. Validation can be described as an external process because it is associated with the needs of the customer, while verification is necessary for compliance with regulations it can be viewed as an internal process. (This concept is described in the PMBOK book Dr. Simon suggested). Examples of medical devices that verification would be sufficient would most likely be products that meet the criteria for a 510(K). For products that have a low enough risk most of the user testing can be conducted in the lab for validation since these products that require a 510(K) would be similar to products on the market.