Qms Tip - Update Your Listing Of Devices With The Fda Before October 1

QMS Tip - update your listing of devices with the FDA before October 1

Medical Device Academy

QMS Tip - make sure you look for changes in FDA forms, not just changes to the regulations

Medical Device Academy

QMS Tip - Combine your CE Marking Procedure with your Medical Device File Procedure

Medical Device Academy

QMS Tip - include specific references to MedWatch 3500A in your complaint handling form.

Medical Device Academy

QMS Tip - Create a quality plan for implementing the FDA QMSR

Medical Device Academy

QMS Tip - Use Asana to manage updates to you QMS. We assign a project section to each procedure.

Medical Device Academy

510(k) Tip - Make sure your IFU template includes all of the FDA eSTAR requirements.

Medical Device Academy

FDA's Transition from CFR 820 to the ISO 13485:2016 Instituting a New QMS

EAS Consulting Group

QMS Tip - October is an ideal time to plan your audit schedule for next year.

Medical Device Academy

QMS Tip - separate your change control procedure from your design control procedure

Medical Device Academy

United States Medical Device Registration Chapter 3 - Quality Management System

FDA Establishment Registration and Listing for Medical Devices

Medical Device Academy

QMS Tip - Reference related work instructions in your procedures

Medical Device Academy

QMS Tip - Do you have a procedure for release of product to a clinical study?

Medical Device Academy

FDA released the new QMSR! Do you need training on it? - Feb. 16

Medical Device Academy

What is the best approach to private labeling medical devices?

Medical Device Academy

How to Prepare a Medical Device 510k Submission for FDA

Matrix Requirements

GMP for Medical Devices Overview ( FDA 21 CFR 820 )

QMS Tip - How can you apply ISO 13485:2016, Clause 6.4.2 to software?

Medical Device Academy