MD20 DESIGN CONTROLS SOP Template
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.
Emailed in PDF format
MD21 DEVICE MASTER RECORD SOP Template
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.
Emailed in PDF format
MD22 DOCUMENT AND CHANGE CONTROLS SOP Template
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.
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MD23 RISK MANAGEMENT SOP Template
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.
Emailed in PDF format
MD25 GOOD DOCUMENTATION PRACTICES SOP Template
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. .
Emailed in PDF format