Uncovering and Managing Successful Postmarket Compliance for Medical Devices: Complaint Handling, Me

When:  Aug 12, 2020 from 8:00 AM to 5:00 PM (ET)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Uncovering and Managing Successful Post Market Compliance for Medical Devices: Complaint Handling, Medical Device Reporting, and Recalls

Customer satisfaction plays a significant role in measuring a product’s post market performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA). Recall compliance involve regulatory obligations as well as proper and timely reporting.  Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumers. The number of device companies having their recall classified as a Class I has surged in the past three years. During this training, we will address all aspect of the recall process. This course will provide an understanding of MDR compliance and the interrelationship of complaint handling, CAPA, and risk management processes. Workshop attendees should expect to come away from this course with a practical framework for understanding recall compliance and the interrelationship from Part I on complaint handling and risk management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Registration Closes:  11 August 2020

Refund Deadline:  13 July 2020


RAC Credits:  12 (Upon attending and completing the program)


Will the meeting be recorded?  No


Registration to 13 July 2020

RAPS Members: $800 

Nonmembers: $900


Registration from 14 July to 11 August  

RAPS Members: $900 

Nonmembers:  $1000


NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. 


Program Schedule 

Wednesday, 12 August (9:00am–5:00pm) 


Topics will include (but not limited to): 


·         Complaint handling and FDA expectations

·         Medical device reporting (MDR) procedures -- regulations, procedures, and malfunctions

·         MDR reporting by firm, agents, and voluntary malfunction summary reporting (VMRS) and eMDR discussion

·         Guidance documents update

·         Being recall ready


Thursday, 13 August (9:00am-5:00pm) 


·         Recalls, Definition and Legal Authority Overview

·         Corrective and Preventative Actions (CAPA)

·         Health Hazard Evaluations HHE/HRA

·         Elements of a Correction and Removal -- 806 Reporting

·         Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)

NOTE: The agenda may vary based on changing requirements.



Rita Hoffman, principal consultant


Cancellation or Substitutions 
RAPS reserves the right to cancel this program at its sole discretion. 

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
Substitutions may be accepted with written approval from RAPS and must be submitted to 
raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.



Call RAPS Solutions Center at +1 301.770.2920, Ext 200


Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.


Registration Form 

If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.


Program Contact

Nichelle Sankey


+1 301 770 2920, Ext 291