This clinical procedure explains the basics of clinical investigations, but if you are looking for a CER procedure you want SYS-041 instead.
Clinical Procedure (SYS-009)
When is the Webinar about this Clinical Procedure?
This webinar will be live webinar on Monday, July 1, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
What you will receive:
The purpose of this (15)-page procedure is to define the process for managing clinical studies and post-market clinical follow-up (PMCF) studies. This procedure provides an overview of managing clinical studies for medical devices. This is the primary document meeting the applicable regulatory requirements for Clinical Studies and PMCF Studies as defined in your company’s Quality System Manual (POL-001). The following is a list of documents included:
- SYS-009 A D5 Clinical Procedure
- TMP-037 A D1 Generic Clinical Study Template
- TMP-038 A D1 Informed Consent Template
- TMP-xxx Clinical Synopsis Template
This procedure is meant to be a high-level procedure for companies that are outsourcing clinical investigations to a Clinical Research Organization (CRO). If your company intends to hire a Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA), then you will need to create work instructions for site selection, site training, site monitoring, patient recruitment, etc.
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
If you would like to learn more about clinical studies, please watch our webinar on clinical study basics with Jan Dugas.
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 510(k) 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.