SOP Medical Device Design and Document Controls

Medical Device Standard Operating Procedure Template- Group MD200 contains MD20, MD21, MD22, MD23, MD24, MD25 and MD26 procedures, forms and log books.

Medical Device Standard Operating Procedure Template- Describes the requirements for the Design Control System which ensures that devices are designed to meet user needs, intended uses, and specified requirements. Package consists of the procedure and a Design Review Report form.

Medical Device Standard Operating Procedure Template- Describes the organization, content, creation and use of the Device Master Record employed in the production of all medical devices distributed by the company. Package consists of the procedure and a Device Master Record Index Log.

Medical Device Standard Operating Procedure Template- Defines the system and assigns responsibilities for the control of documents pertaining to the Quality Management System at the company. Package consists of the procedure, a Document Change Order form, a Document Change Index Log, a Control Number Log, and a Document Change History Log.

Medical Device Standard Operating Procedure Template- Defines and documents processes for addressing device related risks associated with the use and/or handling of the device in order to eliminate, or reduce to acceptable risks associated with the use and/or handling of devices manufactured or distributed by the company. Package consists of the procedure, a Risk Management Plan form, a Risk Management Summary Table, and a Risk Management File Index Log.

Medical Device Standard Operating Procedure Template- Defines the policy of storage, access, preservation, recovery and purging of Quality System Records generated by or for the company.

Medical Device Standard Operating Procedure Template- Describes the company's documentation practices and describes the process for completing Quality System Records, correcting errors, assigning significant figures, rounding numbers, verification of data entries, calculations and other document entries. .

Medical Device Standard Operating Procedure Template- Describes the requirements for organizing the design history file for a device. Package consists of the procedure and a Design History File Index.