SOP Medical Device Management Controls

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- 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.