We
provide consultants experienced in Medical Device and Medical Laboratory
standards and regulations
ER
helps medical device and medical laboratory companies implement ISO
13485, ISO 15189, ISO
14971, or GMP quality systems, obtain the CE
Mark,
submit FDA 510(k) applications, assist with clinical trails, and
more. With offices and associates in the USA, Europe, Canada,
Australia, Japan, and China, we can assist you with most international
quality and regulatory compliance issues.
Funding:
Many of our clients qualify for State and/or US Federal funding for training.
This reimburses costs associated with consulting and
registration. Please
contact us for more information.
FDA 510(k) for USA Market
ER helps support medical
device companies from around the world seeking approval to sell their
products in the United States. One of the first steps for medical device
companies who manufacture Class 2 devices (and a selected Class 1/3
devices) is to file a Pre-market Notification with the Food and Drug
Administration, also known as an FDA 510(k) application. A Predicate
Device – that is a device similar to the one for which approval is
being sought – must already be approved and exist on the US
market.
Our FDA 510(k) submission
and preparation services include:
- Verification that the
predicate device(s) you wish to use in your submission meet the
criteria.
- Research and provide
the required data from FDA Guidance Documents during our review
process
- Contact the FDA Office
of Device Evaluation to determine any requirements for their review
of this product
- Assist in the
preparation of the FDA 510 (k) submission
- Submit the FDA 510(k)
application (or amendment) to the FDA in a consistent manner for all
submissions
- Coordinate and work
with the client and FDA review team. Often additional questions or
more substantiated data are requested by the FDA
- Assist with the
preparation of a response if the FDA has questions or requires
additional information
- Act as the official
correspondent on the application and remain accessible to the FDA
for any future discussions regarding the 510k submission
- Monitor the progress
of the FDA 510(k) through the FDA review process and supply you with
periodic updates as they become available
- Prepare the Safety and
Efficacy summary
- Provide phone
consultation during the FDA510(k) application and 510 k approval
process
ISO 13485 and ISO
14971
ISO 13485 is the quality
management system (QMS) standard specifically designed for Medical
Device manufacturers. It includes 100% of ISO 9000 with extra
requirements for medical devices.
ISO 14971 is the risk
management system standard specifically designed for Medical Device
manufacturers, often integrated into the design and development area of
an ISO 13485 QMS.
If you currently have no
quality management system in place, we will develop and implement an ISO
13485 and/or ISO 14971 system to get your company certified. Each system
is customized for the manufacturer and may include compliance to any
number of country regulations such as: European Union, Canada, USA,
Australia, China, Japan, etc.
For more information on
how we implement a phased approach to QMS development, see our
ISO Management Systems section.
ISO
15189
This
standard is the quality management system (QMS) standard for medical
laboratories quality and competence. It is very specific to clinical
laboratories and in vitro diagnostic test systems.
Typical
ISO 9000 consultants won't do. If implementing ISO 15189, you'll
certainly require the expertise of medical quality consultants such as
Expert Resource. ISO 15189 is very robust and heavy with precise
requirements.
For
more information on
how we implement a phased approach to QMS development, see our ISO
Management Systems section.
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