Mango - QHSE Compliance Software

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.
Reclaim your precious time
Mango QHSEfor Improvements, non-conformances and customer complaints

Saving Time with Health & Safety Compliance

Here are just a few examples of how Mango makes managing your ISO 45001 & ISO 45001 Health & Safety Management System easier, saving you time and frustration.
Policies, Procedures & Forms
Policies, Procedures & Forms
Single source document control is provided within Mango. Add your current policies and procedures into our online editor and forget about uncontrolled copies and hard copy sign off. Cross link your documents to events, personnel, suppliers and risks. No more paper, no more double ups.
Quality  Manual
Quality Manual
With Mango you have one set of viewable, access restricted documents for ease of compliance, and auditing. That means you can remove all of your paper based procedures and ad-hoc document storage.
Reviews & Meetings
Reviews & Meetings
Capture your minutes for all your important meetings such as Product Design Reviews, Product release, Management Reviews, or Tool box Meetings and store these in Mango’s Documents Module making them available to everyone all the time.
Non Conformance & Complaint Reporting & Register
Non Conformance & Complaint Reporting & Register
Log all of your non conformances or complaints data including photos, reports, records and forms directly into the live system and create your Register on the fly. Automatically notify those who need to know about the even immediately to let them take the required actions.
Employee Skills Records
Employee Skills Records
Maintain a record of all your employee skills and qualifications in one central place with a dedicated skills report writer to automatically generate any skills matrix you need enabling you to ensure only trained staff do specific jobs.
Reporting & Charting
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
Medical Device Files
Use Mango's Document & Files module to manage and revision control all of your Medical Device Files.
Unlimited Risk Registers
Unlimited Risk Registers
With Mango's dedicated Risk Management module you can log all managed risks and Product Risks (inline with ISO 14971) set up as many Managed Risk Registers as you need and automate the alerts to have these registers reviewedon a regular basis, capturing the required evidence that it's been done.
Audits and Assessments
Audits and Assessments
Carry out all of your internal and contractor auditing requirements with the Audit Module, for those you can't visit send as assessment from the Assessment Module and upload the data directly to your system. Complete employee competency records using the audit module on the app to record evidence of competency in real time.
Maintenance Plans and Records
Maintenance Plans and Records
Store specific maintenance procedures, forms and records in Mango’s centralised Document module, schedule maintenance or calibration routines and capture maintenance requests in the Plant and Equipment module.
Training Procedures
Training Procedures
Keep your training procedures and job functions for all of your sites in one central location. Let Mango Automate your training and monitoring notifications to reduce time in administration.
Make use of the e-Learning or Assessments Modules to build in house training systems that are fully integrated into your QMS.
Supplier Management
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 imporvements,  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.
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
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
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, carry out maintnenace inspections and much more
Add Images
Add Images
Capturing images directly from the App or from your phone gallery to add more details to your report.
Add Comments
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
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Easily Meet all your ISO Standards requirements

Use Mango to help you meet the following ISO Management and Compliance System requirements.
ISO 50001
ISM Code

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.
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.
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