This procedure is compliant with ISO 13485 and 21 CFR 820.200, and the video below shows you what’s inside our Servicing procedure (SYS-013).
The purpose of this procedure is to define your company’s servicing processes.
This servicing procedure pertains only to physical devices that have been designed to be recalibrated, maintained, repaired or refurbished. In general, disposable products and software products are excluded from the scope of this procedure. This procedure is the primary document meeting the applicable regulatory requirements for servicing as defined in Quality System Manual (POL-001). This procedure applies to medical devices distributed in the United States, Canada and the European Union and has been written to conform with ISO 13485:2016.
Labeling checklist forms and labeling templates are included with the procedure. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-030 A, Servicing Procedure
- FRM-008 A, Nonconforming Material Report
- FRM-013 A, Service Record
- LST-013 A, Service Log
SYS-013 Servicing Procedure – This servicing procedure pertains only to physical devices that your designed to be recalibrated, maintained, repaired, or refurbished. In general, disposable products and software products are excluded from the scope of this procedure. You will need to create your own detailed work instruction for service of your device(s). This procedure applies to medical devices distributed in the United States, Canada and the European Union.
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. To view all available procedures click here.
VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:
About the Author
Robert Packard is a regulatory consultant with ~25 years 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 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.