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  1. The ISO 13485 audit is driven by your QMS Manual that the auditor will follow. Imagine…The QMS Manual is integrated into your QMS and Project management System.
  2. Now Imagine QMS processes that guide your team, helping them to execute their QMS tasks automatically, so they know what to do next and when. Including getting approvals.
  3. Finally Imagine Project Management and Quality Management are combined, leading you to a product and certification.

... Now, That's Wrapper

  • It’s what the auditor wants.
  • It’s what the QMS Manager wants.
  • It’s what the project Manager wants.
  • It’s what your Boss wants. Timely Certification.

Flexible eQMS platform with a touch of a human brilliance to control and manage compliance success, projects, risks and teams.

  • ISO 13485:2016
  • ISO 14971
  • 21CFR Part 820 for 510(K)
  • 21 CFR Part 11
  • CE Mark
  • EU Annex 11

It is also easily adaptable/customizable to ISO 9001, and to many other quality standards.

21-day free trial

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qmsWrapper helps turn medical devices innovation into
reality by integrating 7 critical software modules:

Forms and Form Editor

Forms and Form Editor

Create UNLIMITED FORMS with the Form Builder

Streamline your QMS and choose from 300+ ready-made templates that meet the ISO 13485 requirements, or build and customize forms with a flexible drag &drop to satisfy your specific needs.

Let it be process controls, time sheets, inspection checklists, registers, etc. it’s easy to enter data forms and keep clear records.

  • Keep track of form versions
  • Attach them to any project or task
  • Easy to use Drag & Drop Form Editor
Time Management

Traceability Matrix

ORGANIZE Your FDA or CE Submissions

Ensure you don’t miss any compliance mandatory requirement. Connect documents to project files or to each other, keep them up-to date,  always FDA & CE Mark ready. A godsend for regulatory compliance (and your auditors)!

  • For FDA class I, II, De Novo
  • E Class 1, 2a & 2b
  • Details, Revisions, Relations, Approval History and many more
Quality Management

Quality Management

GET CERTIFIED in LESS TIME with LESS EFFORT.

Maintain ISO 13485:2016 and 21 CFR 820 compliance activities with qmsWrapper: best in class, result-oriented collaborative compliance QMS, specifically designed for medical device manufacturers. Compliance is sewn into the DNA of every module, it’s not a bolt-on QMS system!

  • Quality Manual & Gap Report
  • Validation For Use Documentation Set
  • Workflow Processes + Process Editor
  • Electronic Signature (21CFR11)
  • Approval Workflows
  • Role Based Permissions

With a new innovative approach, it is building an “all-hands-on the deck” system, where each activity has a purpose and the whole team works towards compliance.

Project Management

Project Management

MAKING THE LIFE OF A STARTUP EASIER

A fully-featured, Workflow Process driven Project management. Balance resources, track performance in real-time, organize and manage all your projects and get them done in the most efficient/compliant way!

  • Flexible Workgroups & Customizable Roles
  • Real-Time Issue Tracking
  • Tags: QMS, Milestone, Versions
  • Custom Workflows
  • Workflow Editor
  • Unlimited Projects, Subprojects, Tasks, etc.

From start-to-end, manage your team for success!

Risk Management

Risk Management, ISO 14971

Effectively MANAGE, MITIGATE and PREVENT Risks

In-depth risk management with complete risk assessment, integrated into your entire quality management system. ISO 14971 based guidance combined with a flexible system, including

  • Hazard Control Matrix
  • CAPA
  • Risk Control Processes
  • Action Plan
  • Analysis, Statistics, Reports
  • Automatic Risk Evaluation

...and much more to ensure tracking and mitigating risks before they become expensive and difficult to fix.

Document Management

Document
Management & Control

Stop the QMS Paper-Chase!

A comprehensive and understandable DMC system: track, manage, store and bring company content under control! Designed specifically to support your project development needs and compliance activities, including:

  • Document Approvals
  • Version + File Control
  • Categorize, Classify, & Tag
  • Handling SOP’s, DHFs
  • QMS Vault
  • PIN Signature (ERES)

...and many, many other critical regulatory compliance functionality - this is not a lightweight solution, but the real deal!
It even includes the WrapperApp Desktop Storage application available for Windows, iOS and Linux.

Teamwork Collaboration

Internal Team Collaboration

Collaboration is the glue that binds teams!

No more email ping-pong! Easily connect the whole team. Record and track all internal communication, link the conversation to projects/ tasks as supportive documentation, capture meetings, follow up, keep the whole team focused, up-to-date and productive.
Team collaboration through Project Development and the QMS:

  • Secure, Internal Communication
  • Meetings Management
  • Chat Compliance Docs
  • Sync with Storage
  • and much more.

It’s a great tool that fosters team compliance, so everyone is involved, responsible and works together towards the desired quality outcomes.


qmsWrapper is Unique.
There really is NOTHING like qmsWrapper!
NOTHING!

Execute Your Compliance Strategy and Achieve Success with Powerful Tools!

19 of the qmsWrapper Highlights:

1. FORMS + FORM EDITOR

  • 300+ readymade ISO 13485 Form Templates.
  • Attach any form to any project or task
  • Create, edit and customize your own forms. You can even make them pretty.
  • More info

2. QMS PROCESSES + PROCESS EDITOR

Guide and nurture your team through the development and compliance cycles, step-by-step.
  • Drive out mistakes, and automatically track compliance needs and issues through projects
  • Modify, edit or create new QMS Processes to meet your own particular needs

3. TRACEABILITY MATRIX, FDA 510K & CE MARK

Manage and organize all your CE Technical Files and FDA Device History Files in integrated Traceability Matrix.

4. RISK MANAGEMENT, ISO 14971

Complete risk assessment, effective throughout your product’s entire lifecycle.

5. HAZARD CONTROL MATRIX

Effectively identify, evaluate and mitigate risks through the single matrix interface! Organized with analysis, action plan, CAPA, follow-ups, reports, statistics, evaluation and more.

6. DOCUMENT MANAGEMENT & CONTROL

Robust, comprehensive and automated Document Management for anybody who really hates paperwork!

7. VERSION CONTROL

Keep your whole team on the same page with real-time automated versioning. Have full revision control and version history for any document, file, project, task, etc. whether during an upload, approval workflow, tracking audit records, QMS vault activities, backups, etc.

8. SOPs and DHFs

  • Use default SOPs through Processes, or import your company specific ones, easy to modify or create entirely new, add them into any combination of folders or projects to meet your needs.
  • Produce the documents you need at each stage of production and generate your DHF.

9. CLOUD-BASED SYSTEM + DESKTOP APPLICATION

  • Online: Reach your system from anywhere and anytime.
  • Offline: Work from Wrapper Desktop App and synchronize later online, through secure encryption.

10. TEAM MESSAGING

Secure, internal team messaging designed to support your project development and compliance activities.

11. BALANCE RESOURCES & TRACK PERFORMANCE IN REAL-TIME

Activity dashboard and real-time reports help to better organize projects. Assign the right work to the right team, with the right schedule, and recalibrate work and team members when necessary to utilize resources more effectively.

12. QUALITY MANUAL, ISO 13485:2016

Establish your QM in a day with the built-in, interactive Quality Manual builder tool!

13. GAP REPORT

Find gaps before the auditors do! List all your applicable company processes, print if needed, easy to oversee the steps and find what’s missing.

14. ELECTRONIC SIGNATURES, FDA QSR 21 PART 11

When completing critical or high-importance actions, dual signature compliance functionality is used to securely and positively identify the authorized person.

15. ROLES AND PERMISSIONS

  • Easily match your company roles with the roles required by standard compliance.
  • Flexible workgroups and customizable roles for each project.
  • Role Based permissions ensure the right people access the right data, at the right time.

16. TRANSPARENT ISSUE TRACKING, TRANSPARENT AUDIT TRAIL

Incredible user-friendly UI. Easy to oversee activities, who created the requirement, who is the assignee, tags, who approved it, which version is live, etc.

17. 21st CENTURY QMS, WORKS “RIGHT-OUT-OF-THE-BOX”

Whether you are accidental Quality Manager or a seasoned professional, you can easily step into the role and effectively organize a productive compliance savvy team. Get started in 10 minutes!

18. INTEGRATED, ALL-IN-ONE

Don’t use separate software apps for handling Projects, QMS and Team Communication. Save money, eliminate compatibility issues and keep the focus by not having to switch between apps.

19. DATA SECURITY

Secure system ensures the confidentiality, integrity and availability of your databases.

Skyrocket Your Business

Get serious about regulatory compliance, product development and quality management - qmsWrapper is your BEST solution.

Advantages of an Integrated Software