The change control procedure ensures changes to the design, manufacture or labeling of products is controlled in accordance with regulations.
The video above is announcing a Design Change Control Webinar related to this Change Control Procedure. The webinar will be hosted live on January 20, 2022. The purchase of this procedure includes forms, logs, and a template. These documents are updated for ISO 13485:2016, the Canadian Medical Devices Regulation, and the new European Regulations. The following is a list of documents included:
- SYS-006 A, Change Control Procedure
- FRM-002 A, Training Record
- FRM-012 A, Change Note
- FRM-019 A, Design Requirements Trace Matrix
- LST-009 A, Change Register
- TMP-029 A, Letter-to-File Template (LTF) for 510(k) Cleared Devices
Purpose of this Change Control Procedure
The purpose of this procedure is to ensure that device modifications, manufacturing process changes, and supplier changes within the scope of your company’s quality management system are planned, approved and implemented in a controlled manner, maintaining the safety and efficacy of product and the effectiveness of the quality management system.
Scope of the Procedure
This procedure applies to any medicla device that has been released for manufacture and to any changes to the manufacturing processes or supplier that will result in a change to product or process documentation or that otherwise may potentially have an impact on product characteristics or safety. This procedure meets the requirements of ISO 13485:2016/Amd 2021, SOR 98/282, and Regulation (EU) 2017/745.
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To review a sample Medical Device Academy procedure click below:
About the Author
Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.