Medical Devices Quality Management Software for ISO 13485
Say goodbye to spreadsheets, post-it notes, lost documents and all that wasted time.
Mango makes it quicker and easier to manage every aspect of your ISO 13485 Medical Devices Quality Management Systems saving you time, frustration and money.
Mango makes it quicker and easier to manage every aspect of your ISO 13485 Medical Devices Quality Management Systems saving you time, frustration and money.
Reclaim your precious time
Saving Time with Medical Devices Compliance
Here are just a few examples of how Mango makes managing your ISO 13485 for Medical Devices & integrating ISO 14971 Risk Management for Medical Devices easier, saving you time and frustration.
Policies, Procedures & Forms
Quality Manual
Risk Management Plans
Reviews & Meetings
Non Conformance & Complaint Reporting & Register
Employee Skills Records
Reporting & Charting
The simple report and chart builders allow you to create any report you need and best of all, they are all ways up to date with the latest information.
Medical Device Files
Unlimited Risk Registers
Audits and Assessments
Maintenance Plans and Records
Training Procedures
Supplier Management
Mange suppliers via audits and assessments. Directly link non conformances to supplier records allowing for better performance reviews. Provide them controlled access to your live documentation to ensure they only use the current document revisions.
Say goodbye spreadsheets!
Do more in less time with ISO 13485 & ISO 14971
Say good bye to all the spreadhseets and seperate systems. With Mango you can manage your entire ISO 13485 Medical Devices Quality Management Systems in one place.
Say what you do, do it and most of all prove it by automatically building registers and history of all actions in your medical devices quality management System.
Register all of your improvements, product complaints or non conformances or risks directly into Mango, removing paper and wasted time in alerting people or following up with investigations.
Move your Medical Device quality management documentation on line and let Mango take care of revision control and change management history for you. You can even link between documents to make it easy to move around.
Easily Identify the trends within your quality or Risk management data allowing you to take action to reduce the occurrences and close training gaps.
Keep track of the status of all actions in your quality management system to ensure things don't get held up or forgotten with automatic emails, alerts and esculations.
Automatically link Improvements or non-conformances to internal or supplier audits carried out within Mango to manage the audit findings and ensure close out.
Carry out goods inwards checks on your raw materials or product release audits on finished goods with the audit module, linking any Non conformances or other issues directly with the Improvements module.
Manage all your employee training requirements triggering alerts when training is due, managing the training history and creating your own e-learning system to support the skills in your organsiation.
Create your individual fully revision controlled Medical Device Files automatically recording who approved the files and when.
Use the Management of change module to control changes to both porducts and process to be included in your Medical Device File and Design History Files.
Carry out Product risk analysis inline with ISO 14971 using the Risk Management Module and your own custom risk templates and creating as many dedicate product risk registers as needed.
Use the Risk management module to Identify, assess and then control the aspects and impacts of your policy and operation.
Integrate your internal and external audting program using the audits and assessment modules.
Have multiple risk or hazard registers specific to vehicles, work areas, plant & equipment and more as required.
With the user-configurable workflows you can report, record and investigate everything in a way that works for you from complaints, non confromances, management of change or even maintenance requests.
Automatically alert key personnel when specific types of product defect, non-conformance or complaint Events occur such as Senior Managers or Directors.
Create the reports you need with the inbuilt extensive report writer or chart creator to let you report on anything in the system.
ISO 13485 Compliance on the Free Mobile App
Every one of your employees gets full access to our fully integrated mobile app meaning your team can work with your QHSE system where ever they are.
Recording of Non Conformances and complaints live
Report and manage improvements or non-conformances, complaints, accidents, incidents, risks and hazards on the go. No more filling in paper forms to take back to the desk, do it live on the app.
Complete Audits & Inspections live
Carry out any type of audit or inspection live with the mobile app. Use it to audit internal processes, suppliers, employee training competence, goods inwards inwards or despatch product inspections carry out maintenance inspections and much more
Add Images
Capturing images directly from the App or from your phone gallery to add more details to your report.
Add Comments
Easily add comments to investigations via the app to provide more details or clarifications as part of the investigations.
Works on Android & IOS
See Mango In Action
With the Mango Health and Saftey is built into the system from the ground up. Create an ISO 13485 Medical Devices QualityManagement System that people will actively use, supports all of your system requirements and contributes to the business is easier than you think.
Reclaim your precious time
What People Are Saying About Mango
Don't just take our word about how great Mango is, here is the feedback from some of our users.
Kosie H.
Operations Director (legal services)
Scott G.
Operations Manager
Richard W.
Director
Valerie C.
QHSE Manager
Gillian O
Office Manager
Shona H.
Group QHSE Manager
If you want to check out more independent feedback on how great Mango is head to Capterra.com to hear what others think or you can check out a range of case studies here direct from the end users.
See Mango In Action
Make a booking now to see how simple it is to integrate your systems, reduce paperwork, save time and be compliant.
