Online Safety Community

Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Complaints Handling, Adverse Event Reporting, and Recalls4

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes this fact. The disparate requirements of each regulatory system make it necessary for manufacturers to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

The various jurisdictions, however, deal with post-market device issues in diverse ways. Complaint management, Adverse event reporting and Recalls are three interlocking and interrelated processes that need to go into the QMS.

Corrective action and design changes, which are supporting QMS processes; also need to complement these three processes. And then, the regulatory requirements, which usually involve areas such as recordkeeping and reporting, also come in.

A course on how to implement an integrated QMS

Complaints Handling, Adverse Event Reporting, and Recalls3

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented in relation to the US, EU, and Canadian regulations.

Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management, will be the Director of this two-day seminar. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Want to benefit from Dan’s rich experience and want to understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built? Please register for this seminar by visiting Complaints Handling, Adverse Event Reporting, and Recalls call for .... This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS

Complaints Handling, Adverse Event Reporting, and Recalls1

The extent of its alignment with the FDA’s Quality Management System (QMS) requirement is one of the highlights of the final version of the ISO 13485:2016 standard, which has now become available. The degree of alignment set out in 2016 version of 13485 may be significantly higher than that of the previous version of 2003; yet, there still do exist a few points at which it deviates from the FDA’s QMS. Companies that should comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

Complaints Handling, Adverse Event Reporting, and RecallsUpset man lost in thought having received bad news from his doctor

The agenda of this learning session will be the following:

  • The Regulatory Structure
  • ISO 13485:2016 and regional variants
  • ISO 14971:2007 and regional variants
  • Implementing MDSAP
  • The EU Medical Device Regulation
  • Servicing
  • Identification of problems
  • Servicing data analysis
  • Input to the complaint process
  • Complaints

Identifying complaints

  • Evaluating complaints
  • Investigating complaints
  • Complaint data analysis
  • Input to the corrective action process
  • Input to the risk management process
  • Corrective Action
  • Developing the process
  • Analyzing product and process information
  • Determining subsequent actions
  • Input to the design process
  • Input to the risk management process
  • Design and Design Changes
  • Determining the need for a design change
  • Documenting design changes
  • Design change verification and validation
  • Input to the risk management process
  • Input to the pre-market submission process
  • Risk Management
  • ISO 14971:2007 and regional variants
  • Incorporating post-market information
  • Updating Pre-market Submissions
  • US – The 510(k) guidance
  • EU – Technical files and design dossiers
  • Canada – License changes
  • Adverse Event Reporting
  • US – MDR
  • EU – Vigilance Reports
  • Canada – Mandatory Problem Reporting
  • Recalls
  • US – Corrections and Removals
  • EU – Field Safety Corrective Actions
  • Canada – Recall.


Click here to join us for more information, get in touch

Views: 17


You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
29 minutes ago
Mark Nilson posted events
54 minutes ago
Nakul Pratap posted a blog post
21 hours ago
Elena Lauren posted an event

Live Informatica Training | Informatica Course by Experts - Enroll Now! at 1734 Blue Lake, CT Tarpon Springs FL 34689 United States (US)

March 19, 2018 to December 25, 2018
Why Informatica?Informatica provides the market's leading data integration platform. Tested on nearly 500,000 combinations of platforms and applications, the data integration platform inter operates with the broadest possible range of disparate standards, systems, and applications.This unbiased and universal view makes Informatica unique in today's market as a leader in the data integration platform.Informatica PowerCenter is a premium data integration solution available today.What are…See More


Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla on Wednesday.

Automation Anywhere. How do I pick a value from dropdown

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa Mar 9.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

Proper maintenance for Hi Vis clothing

Can you tell me how to properly take care of Hi Vis jackets? I recently purchased a few ones from this…Continue

Started by Lily Osborn Feb 25.

Forklift Operator Requirements 1 Reply

At our company we have a lot of forklift traffic that has to share the same aisles as our pedestrians. We limit the speed of our lifts to 3 mph.  I am wanting to find out what requirements for…Continue

Started by Rick Briggs. Last reply by Tony Ferraro Feb 25.



© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service