Our service procedure complies with ISO 13485 and 21 CFR 820.200, but now we are adding a training webinar to the bundle for SYS-013.
Service Procedure (SYS-013) Webinar Bundle
The purpose of this procedure is to define your company’s service process. The service procedure pertains only to physical devices that are recalibrated, maintained, repaired, or refurbished. Disposable products and software products are generally excluded from the scope of this procedure. This procedure is the primary document meeting the applicable regulatory requirements for servicing as defined in the Quality System Manual (POL-001). It applies to medical devices distributed in the United States, Canada, and the European Union and has been written to conform with ISO 13485:2016.
When is the webinar about this service procedure?
This webinar was live on Monday, March 25, 2024, at 10:30 a.m. ET. It was recorded. You can purchase it on-demand and watch the training as often as you wish. There are 14 slides in the webinar and the duration of the training is ~30 minutes.
What you will receive:
A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-013, Service Procedure
- FRM-008, Nonconforming Material Report
- FRM-013, Service Record
- LST-013, Service Log
- Native Slide Deck for Training Webinar
- Recording of Training Webinar (March 25, 2024)
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 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 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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.