Using a Complaint Management Software (Medical Device companies)

[mdqprofessional]

Are there better ways to handle complaints for medical device companies?

I'm working with a team that provides quality management solutions for medical device companies and a few teams have approached us to build a better complaint management system. I wanted to gauge interest before we approach an application like this since there are a few competitors in this space:

1) How are you handling complaints right now?
2) Would you use a simple, low-cost complaint management solution to manage things like complaint tracking, MDR assessments, metric trending, risk assessment, etc?
3) What kind of features would you want to see in a complaint management system?

Thanks for the feedback!

 

[J0anne]

1- eQMS and paper based systems (different manufacturers)
2- I already use QMS software
3- The features need to be based on the requirements of whichever QMS the customer wishes to follow.

 

[isoalchemist]

1) paper and home grown system
2) have an QMS system that handles most of that, Complaints/MDR very small usage
3) Features really depend on the focus. What I need would be a good complaint tracking that could turn into an MDR tracking as needs to serve both Customer Service and cross over as needed into the regulated world. With that said a lot of CS systems are industry specific in their layouts so....