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Project & Quality Management System

for achieving and maintaining:

  • ISO 13485:2016,
  • CE Mark,
  • FDA QSR’s (21 CFR 820) and
  • FDA 510(k)
Project & Quality Management System

FDA Clearance, CE Mark or ISO certification
is not only a serious commitment
to your medical product but
also to the quality of that product.

qmsWrapper helps you both organize and
manage the development of your product
and also to keep your commitment to quality.

qmsWrapper does this by integrating and combining
Project and Quality management software into one.

It is built to help you create a safer medical device and
get it to market faster. It helps you organize, manage,
track, cooperate and speed up the product certification process.

FDA Clearance, CE Mark or ISO certification is not only a serious commitment to your medical product,but also to the quality of that product.

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

Quality becomes not just a buzzword but a means to get things done.

It transforms compliance from concept into a true competitive advantage.

Companies that deliver the best quality products and services efficiently - succeed.

Essentially, qmsWrapper meets the core needs of MedTech companies and is particularly well suited for:

  • Start-ups and Smaller companies

    Developing Class I, Class II, and DeNovo (seeking Class II) devices and

    seeking 510(k) or De Novo clearance

  • MedTech companies

    Developing CE Class I, Class IIa and Class IIb and

    seeking CE Mark

  • Managing projects with the following compliance needs:

    FDA QSR 21 CFM 820,

    ISO 13485:2003, and

    ISO 13485:2016

qmsWrapper is an all-inclusive integrated software that includes:

...it effectively eliminates the need for multiple software applications and
a separate, “bolt-on”, quality system.

  • Each module exists both as a separate module
    so you can work within each as needs arise,
    but also, they exist as highly integrated and
    interconnected to maximize productivity and
    provide a 
    seamless team based compliance experience.

  • The advantages of such an integrated PM+QM system
    is that FDA or ISO compliance is not limited to “reporting” or
    to the tracking of reports, but rather they are integrated
    right into your workflow processes directly,
    so quality becomes everyone’s business throughout the workday,

    we call that Managing Through Quality (MTQ).

qmsWrapper is an all-inclusive integrated software

Quality managers with little experience or knowledge of the supported Standards, can easily step into the role and effectively start.

Quality managers
with little experience

or knowledge of the supported Standards,
can easily step into the role
and effectively start.

qmsWrapper provides a step-by-step sequence of tasks
with appropriate explanations, and cautions,
to help QMS Managers correctly perform their job.

  • Workflows Processes define
    the many or few steps needed to complete
    a set of Quality requirement tasks –
    without missing a step.

    The QMS Workflow Processes help reduce
    errors, forgotten paperwork, missed QMS reports.
    Users know exactly what to do when to do it,
    and how to complete a compliance requirement
    within their assigned set of project tasks,
    that are monitored and managed
    by management automatically.
QMS Workflow Processes
QM module virtually mirrors the PM and the DMC
  • In qmsWrapper, the QM module
    virtually mirrors the PM and the DMC
    tracking all the QMS events for each of the projects
    as they are defined in the PM module.

    This mirrored approach means
    a QMS Manager does not need to chase
    the project members for compliance issues –
    rather the issues come to them.
  • There is no need for the QMS manager
    to shadow the Project Manager.
    There is no QMS paper-chase.

  • The flip side of this approach is that
    project members are automatically included
    in the compliance process
    as the QMS workflow processes will
    automatically include them in whatever
    compliance issue is necessary and
    at what point it is necessary, including
    identifying what form to complete
    and what to do with it.

Organizational Chart

A QMS Processes Driven Project Management ensures that the projects are managed in a most efficient way. qmsWrapper includes 89 default process workflows that are predefined according to the ISO and FDA standards.

Process Editor
  • To further improve flexibility,
    we built an ultimate Process Editor
    that allows customers to customize
    the default QMS Processes or SOPs
    to fit their company’s particular workflow needs,
    or build new processes from scratch,
    just by following few easy and simple steps.

The QMS documentation – especially for a complex project – can be endless and daunting.

qmsWrapper is designed to find a needle in the haystack, any document can be listed and filtered only for the desired process, furthermore, all document searches are fast, and results are returned immediately.

  • A comprehensive DMC includes file version control,
    detailed history, tracking, tagging, comments
    and authority control, full support for document search.

  • Secure data management with QMS Vault, ERES,
    and role-based permissions access.

  • Includes a built-in Quality System Manual builder tool.
    The Quality Manual defines the qmsWrapper and
    the processes used.

    Certification audits all start with the manual, now
    the manual is the start of qmsWrapper.

    This tool simplifies the process of establishing
    the quality manual that correlates directly with qmsWrapper
    and the Processes used.

The QMS documentation

It will save hundreds of hours of documentation work for your teams.

It will
save hundreds of hours
of documentation work
for your teams.

ISO 14971 based

flexible Risk Management,

where you can create your own Risk Analysis in any process,
and define your own risk varieties and action plans.

It was built with an integrated approach
to manage risk across an organization.

It’s flexible so it can be appropriate and
proportionate to the complexity and type of organization involved.

Create your own Risk Analysis in any process
Increase in productivity and efficiency

The continuous improvement,
tracking and measuring of your operations
inevitably leads to an increase
in productivity and efficiency.

qmsWrapper, makes the process of achieving and maintaining ISO,
CE Mark or FDA compliance as painless as possible,
without the need for a 2nd bureaucracy to manage it.

If you’re ready to get serious about your quality management and
product development efforts, qmsWrapper is your solution

Start Managing Through Quality Today!