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Quality Management Software for
Medical Device Creators

Complete
Complete
Complete
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Now Includes

Traceability Matrix

  • Organize
  • Connect
  • Trace
  • Manage

qmsWrapper solves all our regulatory problems, in one system, while saving us £1000's over our previous QMS system.

Jonathan E.

It's everything you'll need for your FDA and CE mark submission

Some Essential eQMS Functionality

Document Management & Control

  • Document versioning and history
  • Approved and active status of the document
  • Document vault
 

Create QMS Processes according to your SOP’s

  • Hundreds of prepared and validated Processes for ISO 13485.
  • Process Editor: modify, edit or create new ones
  • Automatically track compliance needs and issues
 

Interactive Quality Manual Creator and GAP Report Tool

  • Follow and edit all the chapters of the ISO 13485 standard.
  • Connect your processes with paragraphs in Quality Manual
 

Traceabitliy Matrix

  • Make FDA 510K & CE MARK submissions easier
  • Manage and organize all your CE Technical Files and FDA Device History Files.
 

Risk Management, ISO 14971

  • Complete risk assessment tool.
  • Hazard control Matrix
  • Identify, evaluate and mitigate risks through the single matrix interface!
  • Support for Risk assessments conformant with ISO 14971
 

Regulatory Compliance

FDA and ISO 13485

FDA and ISO 13485

Organize and manage the development of your product and to keep your commitment to quality.

 
QMS for Beginners

QMS for Beginners

Step by step guide about Compliance (ISO 13485:3016, CE Mark, U.S.QSR (21CFR 820) for510 (K))

 
ISO 9001 Checklist

ISO 9001 Checklist

Checklist for implementing a QMS for ISO 9001-2015

 
ISO 13485 Checklist

ISO 13485 Checklist

Checklist for implementing a QMS for ISO 13485-2016

 
 

Traceability Matrix

Organize Your FDA or CE submissions.
Don't miss mandatory compliance requirements.

Learn more

 
 
  • Proven document control
  • Connect documentation with processes
  • Integrated with project
  • Define all requirements you need for sucessfull completion of your project.
  • Export into print ready format for your FDA submission
  • Reduce project risk
 

Some Key Supporting Features

ELECTRONIC SIGNATURES - FDA QSR 21 PART 11

Our secure and unique signature supports FDA QSR part 11 as a 4 digit PIN for each user. It is essential for any document approval or moving document to QMS folder and QMS Vault on Storage.

Dual signature compliance functionality is used to securely and positively identify the authorized person.

DATA ACCESS AND SECURITY

qmsWrapper is a secure, confidential and closed system. Safeguards ensure authorized person access to data.

Built-in document versioning and continuous, encrypted, off-site multiple location/ GEO regions storage backups are protecting your data in case of disasters.

CAPA ISSUE TRACKING AND AUDIT TRAIL

Monitor and manage CAPA activities, related processes, the user who created the requirement, who is designated.

Multi-step CAPA - track progress, tags, approvals, versions, etc.

ROLES AND PERMISSIONS

Match your company roles with the roles required by standard compliance.

Flexible workgroups and customizable roles for each project.

Role-based permissions

CAPA

Initiate a CAPA process within a project, triggering a specific sequence of events required to resolve the QMS issue.

Trace, follow, validate!

TEAM MESSAGING AND MEETING MANAGEMENT

Secure, team messaging designed to support your project development and compliance activities. Maintain a record of all meetings and associated documents.

You’ll likely never use email again!

CENTRALIZED STORAGE

Track documents easily with storage organization and advanced document search filters.

Search any issue, in any project in any task, on any day, at any stage of completion.

FORMS AND FORM EDITOR

Use custom forms to meet your specific needs. Create any form you need for the project you need it in. Collect and maintain records in a nicely formatted and easy to read manner.

Data is saved in a dataset and can be searched and recovered quickly.

EMPLOYEE TRAINING

Develop and implement a successful training program according to your needs with our custom process editor and always keep appropriate records of training.

LEARNING TUTORIALS

Visit our Help Center for answers to frequently asked questions and instructions on how to use the qmsWrapper software.

We are always ready to help!

Huge Time saver

 
 
  • Interactive
  • Interconected
  • Integrated
  • Customizable
  • Easy to update
  • Form assistance

Huge Time saver

Quality Manual Creator & GAP report tool for ISO13485:2016

Establish your Quality Manual in a day!
Yes, it's that easy with qmsWrapper!

Learn more

 

It has all features you need, without using any third party software.
Let the processes guide you through ISO 13485:2016 with the relevant templates included.

Richard M.

see qmsWrapper in action

One of our qmsWrapper experts
would love to give you live demo.

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qmsWrapper made it easy for the auditors to track our CAPA to the related task in the project.

Ivana K.
 

Skyrocket Your Business

Get serious about regulatory compliance.
qmsWrapper is your BEST solution.