Using a Complaint Management Software (Medical Device companies)

  • Thread starter mdqprofessional
  • Start date

Would you use a simple, low-cost complaint management software?

  • Yes

    Votes: 0 0.0%
  • No

    Votes: 1 100.0%

  • Total voters
    1
  • Poll closed .
M

mdqprofessional

#1
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!
 
Elsmar Forum Sponsor
#2
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.
 
I

isoalchemist

#3
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....
 
Thread starter Similar threads Forum Replies Date
J Using Complaint Rate to Update FMEA P.O.C ISO 14971 - Medical Device Risk Management 4
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
John Broomfield Workplace by Facebook - Any other organizations using this collaborative tool? Misc. Quality Assurance and Business Systems Related Topics 0
I Flatness - Rectangular part using the three jack method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
JoshuaFroud How important is using the "correct" GMDN? Other Medical Device Regulations World-Wide 13
A Overkill? Using the 3L5W tool on non-conformities Nonconformance and Corrective Action 3
M GD&T tolerance or band? Using a symbol like parallelism // Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
B Informational Expanded Gage R&R Analysis using Minitab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 18
S Evaluating the possibilities of using qmswrapper or greenlightguru Document Control Systems, Procedures, Forms and Templates 4
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
V Using K-Factor(Tolerance Interval) Analysis for Design Verification Statistical Analysis Tools, Techniques and SPC 3
O Which is better - Quietly quit using a supplier or tell supplier? Supplier Quality Assurance and other Supplier Issues 11
A Capability Analysis for Packaging Seal Strength with spec. >0.1 Kgf using Minitab Using Minitab Software 6
J Layered Process Audits using Kamishibai Board Process Audits and Layered Process Audits 3
Q How can you justify using a more accurate Pin Gage class? General Measurement Device and Calibration Topics 16
S Basic Dimension W/O using FCF Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
G How to compute or estimate a micrometer or caliper flatness using optical flat General Measurement Device and Calibration Topics 2
rob73 Requirement for independent certification of device using an ISO 17025 laboratory EU Medical Device Regulations 2

Similar threads

Top Bottom