GMProcedures™ MD series-SOP Templates for Medical Device Manufacturers

Medical Device Standard Operating Procedure Template Group MD100 contains MD10, MD11, MD12 and MD13 procedures, forms and log books.

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; Group MD300 consists of MD30,MD31,MD32, MD33,MD34,MD35 and MD36 procedures, forms and log books.

Medical Device Standard Operating Procedure Template Group MD400 consists of MD40, MD41, MD42, MD46, MD47, MD48 and MD49 procedures, forms and log books.

Medical Device Standard Operating Procedure Template Group MD500 consists of MD50, MD51, MD52, MD54, MD55, MD56, MD57, MD58, and MD59 procedures, forms and log books.

Medical Device Standard Operating Procedure Template- Describes the responsibilities of Executive Management for establishing, implementing and maintaining the Quality Management System, reviewing the suitability and effectiveness of this system, and providing resources to implement this system, maintain its effectiveness, and meet regulatory and customer requirements. Also describes management's responsibility for Risk Management and customer requirement related activities. Package consists of the procedure, a Management Activities Log and a Management Review Record form..

Medical Device Standard Operating Procedure Template- Describes the process and instructions for performing Quality Audits to assess the Quality Management System performance, assure it is in compliance with established requirements, and is operating effectively. Package consists of the procedure, a Quality Audit Nonconformance Report, an Internal Quality Audit Report, and a Quality Audit Log.

Medical Device Standard Operating Procedure Template- Describes the process for managing visits by regulatory agencies having legal authority over medical devices manufactured or distributed by a company. Package consists of the procedure, a Regulatory Agency Daily Visit Record, and a Regulatory Agency Visit Log.

Medical Device Standard Operating Procedure Template- Describes a system that assures that all personnel are qualified and adequately trained to properly perform their assigned responsibilities. Package consists of the procedure, a Training Attendance Record form, an Employee Training Plan form, an Employee Job Description form, and an Employee Training Log.

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.

Medical Device Standard Operating Procedure Templates- Describes the systematic approach used to collect and analyze information, identify and investigate product and quality issues, and take appropriate and effective corrective and preventive action to deal with product and quality issues and prevent their recurrence. This procedure also discusses the communication and documentation activities associated with the corrective and preventive action system. Package consists of the procedure, a Corrective and Preventive Action Report form and a Corrective and Preventive Action Report Log.

Medical Device Standard Operating Procedure Template- Describes instructions for performing servicing of finished, distributed medical devices and verifying that the serviced devices meet specified requirements. Package consists of the procedure, a Service Report form, and a Service Activities Log.

Medical Device Standard Operating Procedure Template- Describes the requirements and process for determining whether a product recall, field correction, or removal is reportable to the FDA and to define the reporting requirements for such actions that are initiated by the company. Package consists of the procedure, a Recall Action Report form and a Recall Action Log.

Medical Device Standard Operating Procedure Template- Describes the procedure for the mandatory reporting of adverse events and product problems to the FDA in accordance with the FDA's mdeical device reporting requirements. Package consists of the procedure and a Medical Device Report Log.