Are you a FDA Medical Device Manufacturing firm that is looking to improve
your Quality System by adding ISO 13485:2003 to your list of registrations /certifications?
Or are your customers requiring this additional registration/certification.
WE CAN HELP!. There are few industries where the importance of product conformity
is as crucial as that in the design, manufacture and testing of medical devices.
The certification of a quality management system, specific for
Medical Devices will be to your advantage and in many cases is required
for customers or organizations who export their products to the global market.
The standard is mandatory for medium and higher class medical devices
in Europe and Canada. ISO 13485:2003 is a stand alone standard specific
to medical device quality systems. It contains requirements relating
to design controls, process control(including environmental),validation and verification,special
processes, traceability, record retention and regulatory actions,
which are critical for the medical device industry.
Who would want to be certified to ISO
13485?
* Organizations currently manufacturing private label medical devices, but
are looking at eventually selling their product in the European Union.
* Organizations, such as consulting shops, which design,
manufacture and assemble medical and In Vitro diagnostic medical devices
and component manufacturers.
* Organizations that manufacture In Vitro Diagnostic Medical
Devices that want to be prepared for any future regulatory requirements.
Our auditors have had many years of hands on experience in the Medical Device industry. Just
by watching them audit you can learn more.
DAC Audit Services can help you with system support
and registration.
Contact us for more information at 978-386-2516 or click on Contact Us.
