Chapter 17, Additional Exercise 3: Evaluating a Directive

The following report could be improved in tone, substance, and structure. Revise it to increase its effectiveness, adding any reasonable details.

KLINE MEDICAL PRODUCTS

Date: 1 September 2015

To: Mike Framson

From: Fran Sturdiven

Subject: Device Master Records

The safety and efficiency of a medical device depends on the adequacy of its design and the entire manufacturing process.

To ensure that safety and effectiveness are manufactured into a device, all design and manufacturing requirements must be properly defined and documented. This documentation package is called by the FDA a "Device Master Record." The FDA's specific definition of a "Device Master Record" has already been distributed.

Paragraph 3.2 of the definition requires that a company define the "compilation of records" that makes up a "Device Master Record." But we have no such index or reference for our records.

Paragraph 6.4 says that any changes in the DMR must be authorized in writing by the signature of a designated individual. We have no such procedure.

These problems are to be solved by 15 September 2015.