Course code DD1

Medical Device Design and Development Control

Qserve, in association with Qserve America, has developed a course for medical device industry professionals which cover the following aspects of medical device design and development control. Qserve offers this course in English or in Dutch, at Qserve offices, external locations and on-site at your own organization. This course can be concluded, if required, with an examination and/or certificate.

Course Description:

The following design elements are looked at:

• Planning and effective design philosophy
• Implementing the design Procedures (SOPS)
• Using a Design Matrix from input to output
• Tools for efficient project management
• Assigning responsibilities in the design process
• Effective use of risk management techniques (ISO 14971)
• Quality system strategy for compliance (ISO 13485)
• Use of International Standards and regulations (e.g. GHTF / FDA / CMDR / MEDDEV guidelines)
• Product and process and validation: IQ, OQ, PQ and PPQ
• setting up a Master Validation Plan (MPV)
• Effective manufacturing transfer procedure
• Compiling Design History File (DHF)
• Design review and verification
• Design change control
• Compiling a Device Master Record (DMR)
• Compiling a Design History File (DHF)
• Writing & Implementing "Design" Standard Operating Procedures (SOP) conform ISO 13485 and /QSR requirements
• Effective manufacturing transfer procedure

This extensive course emphasizes the importance of a structured approach to the design and development process, using the applicable guidelines and regulations, for the shortest and (fastest) route from "concept" to "market ready" device. All elements of the design and development process are considered from planning, design inputs to outputs (design matrix), review, verification, validation, and design change, thru to the compiling of the “Design History File” (DHF) in which each stage of the design and development process must be documented.

Product development drives business growth, but, in the medical device sector, is relatively expensive. Qserve's training will guide you in the best way to "build" medical devices right the first time and every time!

Qserve's structured and practical approach to the design and development process will ensure that you do not get "side-tracked", wasting time and money in getting your product to market, but allow you to get the highest return on your innovation investment.

Who should attend:

This course is intended for:

• R&D Teams
• Project M managers
• Regulatory A affairs Personnel
• Quality management Managers

The duration of the course can be customized to your requirements. Participants will receive a comprehensive course manual with reference materials and an attendance certificate upon successful completion of the course . If required the course can be concluded with an exam.

For more information, please complete the info request form in the Contact section, quoting the course code.