Qserve America offers a broad range of services including:
Strategic planning
Many companies have a great concept for a new device or a line
extension, but have no idea what regulatory pathway to follow
or, even worse, select the wrong one, resulting in unnecessary
expense and lost time. Qserve will work with you to identify
the optimal regulatory pathway and submission strategy to get
your product to market with the best clinical indications for
use and in the least amount of time. With a broad knowledge
of the FDA device classification system and an extensive network
of contacts within the FDA, Qserve can determine when a product
can be submitted following a standard procedure and when a meeting
with FDA is appropriate. Qserve will be at your side at any
such meeting, acting as your interface with the FDA.
510(k), IDE, PMA
Whatever classification your device falls into: Class I, Class
II or Class III, Qserve can help you. We can prepare your regulatory
documentation, submit it to FDA, follow it through the process
and help answer any questions FDA may have. As your Official
Correspondent, we will be the first point of contact with FDA,
sparing you from any concerns about dealing with a US Federal
Agency with which you may be unfamiliar.
QMS
Knowledgeable about all the major quality systems (e.g. FDA
QSR, ISO 13485, CMDCAS), Qserve can help you build a quality
system that not only addresses regulatory requirements, but
that will truly function as an effective and efficient management
system. If your system is already in place, Qserve can assess
it for compliance with the relevant requirements and provide
assistance in modifying your system to comply as needed. For
small organizations in start up or pre-start up mode, Qserve
can provide part-time management of all quality and regulatory
functions, saving you the expense of hiring personnel before
they can be fully utilized.
Pre(clinical)
With a thorough knowledge of FDA regulations and guidance documents,
and working with the experts in the Qserve Group, Qserve American
can identify the bench and animal testing requirements that
may exist for your device. Because of our knowledge of the various
regulatory requirements in places such as the EU and Canada,
we can save you valuable time and money by ensuring that testing
is done to satisfy these multiple regulatory requirements, another
advantage of working with a company with international experience.
Because Qserve has associations with major test houses around
the world, we can recommend the appropriate off-site testing
facilities, as needed, and we can mange the entire process.
US Agent
Foreign companies must have a US Agent that the FDA can contact
as needed. More than just an address, Qserve America also will
complete and review the forms you must file with FDA, such as
Establishment Registration and Device Listing, to ensure that
your organization and products are properly registered with
FDA.
Training
Qserve offers a wide range of training services. These include
training in basic QMS, such as FDA Quality System Regulations
(QSR), ISO 13485 and CMDCAS, as well as more advanced training
in specific topics, such as Medical Device Reporting/Vigilance,
Design Control, Validation and Project Management. Training
is customized to audiences ranging from Senior Management to
manufacturing line operators. Training can be done on site or
at a central location. Courses can be conducted in as little
as half a day or over multiple days as needed.
Audits
In order to assess an organization for compliance to the appropriate
regulations and standards it is necessary to audit the various
processes and functions within that organization. Qserve provides
Gap Analysis audits of all relevant processes, including design
control, quality systems, management responsibility, process
control, validation, maintenance and calibration, training,
distribution, corrective actions/preventive actions (CAPA),
complaint handling, and medical device reporting/vigilance.
More than just auditing, based upon many years of industry experience
Qserve will recommend practical solutions to any observations
to enable your organization to come into full compliance in
the most efficient way possible.
In the event your company is inspected by the FDA, another regulatory
agency or a Notified Body (NB), Qserve can attend the inspection
and serve as a liaison between your company and the auditor(s).
This can be especially useful when language may be an issue.
CE Marking
As a member of the Qserve Group, Qserve America can help you
achieve CE Marking for your device either independently or concurrent
with your US regulatory strategy. This is another advantage
of working with a company that has an international scope. With
our knowledge of the EU MDD and our relationships with all the
major Notified Bodies (NB), we can help select the NB best suited
to your particular
Validation
Process and product validation come in many forms, for example
equipment, environment (e.g. clean rooms), sterilization (heat,
EtO, gamma) process lines and software. While each has the ultimate
goal of proving with a statistically valid degree of confidence
that the product or process reliably performs as intended, the
methods for performing these validations vary widely. With years
of experience in process and product validation and with the
ability to utilize the experts of the Qserve Group as needed,
Qserve America can work with you to develop your validation
protocols. Because of our association with major test houses
around the world we can recommend third parties that can perform
the more complicated validations and Qserve can manage the entire
process, freeing your personnel to work on other projects.
Authorized Representative
Foreign companies that wish to sell their products in the EU
must utilize the services a European Authorized Representative
(AR), who has a physical address in the EU and who is responsible
for interacting with the Notified Bodies on matters such as
Adverse Events (Incidents). Qserve works with Obelis, the preeminent
AR in Europe and is pleased to recommend their services. Obelis
will ensure that your organization is in full compliance with
all of the regulations mandated for an AR. Again, because Qserve
works with your AR, there is an efficiency obtained through
the elimination of redundant and/or incorrect procedures.
(http://www.obelis.net)
Distributor Search
Because of our long association with various large manufacturers
and independent distributors, if your organization does not desire
or lacks the capacity to distribute your product, once it is able
to be marketed, Qserve can help you find the best fit for a distributor
or for a licensing agreement.
