A change control procedure ensures changes to the design, manufacture, or labeling of products are controlled in accordance with regulations.
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 the product and the effectiveness of the quality management system.
When is the Change Control Procedure Webinar?
The change control procedure webinar will be hosted on August 5, 2024 @ 10:30 a.m. ET. The webinar will be live, and you will receive login instructions if you purchased the change control procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.
What is included with the Change Control Procedure?
The purchase of the Change Control Procedure includes forms, logs, a template, and a training webinar. These documents are updated for ISO 13485:2016, the Canadian Medical Devices Regulation, and the new European Regulations. The following items are included:
- SYS-006 A, Change Control Procedure
- FRM-012 A, Change Note
- LST-009 A, Change Register
- TMP-029 A, Letter-to-File Template (LTF) for 510(k) Cleared Devices
- Native Slide Deck
- Login Information for the Live Webinar (if purchased on or before August 5, 2024)
- Recording of the Webinar (after August 5, 2024)
Scope of the Procedure
This procedure applies to any medical 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 impact product characteristics or safety. This procedure meets the requirements of ISO 13485:2016/Amd 2021, SOR 98/282, and Regulation (EU) 2017/745.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
The video above announces a Design Change Control Webinar related to this Change Control Procedure. The webinar was hosted live on January 20, 2022, and a webinar recording is available on-demand if you follow the above link. The presentation had 37 slides, and the recording duration was 57 minutes. This video is also included in our Turnkey Quality System.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
About Your Instructor
Rob 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. Rob 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 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.