Purpose – The purpose of this procedure is to define the process for performing a clinical evaluation in accordance with MEDDEV 2.7/1 rev 4.
Scope – This is the primary document meeting the applicable regulatory requirements for Clinical Evaluations as defined in the Quality System Manual (POL-001). Generally, this requires clinical data (Annex X, §1.1, MDD). Annex X, MDD. Consultants that are providing services and have been approved by the company may rely on their own procedure(s) instead of this procedure. Qualification and evaluation of a consultant is controlled by the Supplier Quality Management Procedure (SYS-011)…
2. Literature Search Protocol (TMP-004)
Updated Blog on MEDDEV 2.7/1 rev 4
In June of 2017 the fourth revision of the guidance document for clinical evaluations was released. An overview explaining the updated version of the guidance document can be found in the Medical Device Academy Blog by clicking here.
What will you receive when you purchase this bundle?
Anyone that purchases the clinical evaluation procedure and webinar bundle will automatically receive both the updated version of the Clinical Evaluation Procedure (SYS-041), any future updates to the procedure, the associated literature search protocol template and access to the webinar.
Typically webinars are sold on our website for $129 and procedures are sold for $299. This bundle is sold for $299. As always, you receive a copy of the native slide deck and a link for downloading the recording.
When is the webinar for the Clinical Evaluation Procedure?
The webinar will be conducted live on Friday, January 27, 2017 @ Noon EST. The recording will be available for download later that day.
During the original live webinar, you can submit questions via email or the chat box. If you have company-specific questions, or you are purchasing the recording after January 27, 2017, please send me a request to set-up a private call to discuss your specific issues.
Clinical Evaluation Procedure and Webinar Bundle available for $299.00:
Important Note: If you already purchased the previous version of this procedure you will receive the procedure update and webinar bundle at no charge.
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.
About Your Instructor
Rob 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. Rob 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. 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.