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Leadership through Quality Assurance and Compliance |
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| BioMeridian manufactures Class IIa medical devices. These
are regulated by the United States Food and Drug Administration (FDA). Our
machines are GSR (Galvanic Skin Response) devices for Meridian Stress
Assessment. As such, we are under specific mandates to perform to certain
measurable criteria that is established, updated, monitored, audited and
enforced by the FDA. |
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Overview of Requirements |
| We are required to operate under an FDA 510 (K)
registration. We are required to validate the safety and effectiveness of
our products. We are required to establish and maintain a Quality System. We
must comply with current MDR (Medical Device Reporting) regulations. Over
and above this and other mandatory regulations we choose to test our
products to the highest standards set by governments the world over. Below
and in the links provided you will find specific information regarding these
types of regulatory requirements that sets BioMeridian apart as an industry
leader. |
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FDA 510 (K)s |
| The United States Food and Drug Administration (FDA)
determines and regulates the status and classification of all medical
devices that are sold in the United States. Individuals and companies
cannot, of themselves, determine if their device is medical or non-medical,
nor can they decide what classification, if any, a device falls into.
BioMeridian's current line of GSR (Galvanic Skin Response) devices are
regulated and fall into a Class IIa medical category. It was necessary for
us to apply for and be granted an FDA 510 (K) market clearance. This allows
us to market our devices, with certain restrictions, here in the US. Our 510
(K) is only the first step. There are many other requirements we and any
manufacturer, must continually meet. |
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View BioMeridian's 510 (K)
Information |
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FDA Quality System Requirements (Good Manufacturing Procedures) |
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the FDA has approved or allowed the use of a medical device in the US
market, they have established a comprehensive set of standards that
manufacturers must adhere to. These requirements or procedures are mandatory
and enforceable by the FDA. This is an ever evolving set of instructions
that all manufacturers must understand, implement and live by. The FDA can
audit any manufacturer at any time and determine how well these rules are
being followed. The FDA has the right to require corrective action on the
part of a device manufacturer to ensure that these standards are adhered to.
The FDA can enforce recalls, effect changes and in extreme cases demand the
seizure of product or revoke the manufacturer's ability to sell. BioMeridian
is constantly striving to maintain, expand and perfect these on-going
standards. |
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Introduction To Good
Manufacturing Principles By The FDA |
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Third Party Testing and Verification |
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meet many of the requirements of the FDA's Quality System it is necessary to
have medical devices tested by outside, third party, accredited facilities.
The extent of testing required depends on the classification of the device.
In the case of the products manufactured by BioMeridian, the testing is
extensive. We are required to pass safety issues, radiated emissions, air
discharge tests, contact discharge tests, electromagnetic field tests, power
frequency tests and a host of others. These tests are time consuming and
expensive, often taking months and costing vast amounts of capital.
BioMeridian not only complies with these requirements here in the US, but
often exceeds them, as we also test for stringent requirements on the world
stage. |
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View
Our Verification Certificate |
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View Our
Testing Documentation |
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World Class Compliance: European Union Standards - CE Mark, CB Scheme
member |
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BioMeridian also sells its products in foreign markets. Many of the
requirements that the FDA mandates here in the US are also mandatory abroad.
There are also requirements that go beyond the US procedures. The most
common is called the CE mark. There are currently 24 countries around the
globe that require the CE mark on any product sold within their borders.
BioMeridian meets these requirements and currently has passed all the
testing and has a CE mark on all of its products. Moreover, many nations
that are not part of the CE mark with the European community, are part of a
program called the CB Scheme. This means that many, if not all, of the test
requirements for these countries fall within the procedures needed for the
CE mark. This makes BioMeridian a truly globally compliant company, with the
ability to sell in literally any market. This gives extra assurance to you,
the customer, that we manufacture to world class standards. |
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ISO 9001:2000 BioMeridian Standards |
| BioMeridian International is pleased to announce it has
received certification from Orion Registrar, Inc. USA for ISO 9001:2000.
The company achieved this goal on September 29th, 2005 thus adding to our list
of international certifications. To see a copy of this certificate click
here. |
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ISO Registration
Certificate |
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ISO 9001:2000 Manufacturing Standards |
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term ISO is heard a lot. It stands for International Standards Organization.
This group sets up manufacturing standards and procedures to ensure
consistency in product production and to establish a system for determining
and checking the quality of any given product. BioMeridian requires its key
product vendors to be certified to these high international procedures. The
primary hardware piece in all of the products we sell is the electronics.
All of our electronic components are manufactured to the latest ISO
standard. Our current main electronics vendor is Newonics, located in the
state of Utah. At our insistence, other key vendors are in the process of
completing their individual ISO testing and are on target to be certified
this year. |
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ISO Registration
Certificate -
ISO Manufacturing Facility |
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BioMeridian Quality Assurance |
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Meeting the FDA's Quality System Requirements (Good Manufacturing
Procedures) goes beyond testing products for compliance in the US and
abroad. It means that companies must have an acceptable Quality Assurance
system in place that meets specific FDA requirements. It means that we must
implement and use this system on a daily basis. It includes, but is not
limited to, the following items: device design specifications, product
labeling, packaging specs, policy objectives, management responsibility,
quality plan, quality audits, design review, design validation, document
control, purchasing controls, approved vendors, inspection, corrective and
preventative action, etc. Everyone at BioMeridian plays a role in the
Quality System. Everyone, from management to the smallest vendor, is
responsible and proud to build the finest quality product. |
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Outline of BioMeridian's
Quality Assurance Manual |
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Customer Service |
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Tracking and solving problems and questions that come up in the field is
more than a good way to do business. The FDA makes it mandatory that we have
an effective and approved method for Corrective and Preventative Action.
This means that we record ALL customer calls that come in. We then routinely
review and analyze these records to see if there are any patterns or
incidences that indicate problems that need to be addressed immediately or
in the long term. The first response is to correct any problem in the field
as fast as possible, so our customers can use our products safely,
consistently and effectively. The second tier is to correct future problems
before they occur. This is an on-going task of the BioMeridian Development
team and management. Weekly development meetings focus on ways to improve
product performance and reliability in real-world field applications.
On-going development and research look for long term answers and new
technologies that will make our products more effective, easier to use, more
reliable, and more affordable. |
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Visit BioMeridian Customer
Service |
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| Would you like to learn more?
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Request More Information Now |
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| Study Groups NEW |
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BioMeridian study groups are informal events, hosted by a BioMeridian representative,
designed to ensure access to local, hands-on support, for our customers after they have
received basic training. The study groups are held regularly throughout the country to
ensure each of our customers has the chance to receive continued support and the opportunity
to meet other practitioners in the field. These events are for practitioners (or staff)
only and are not appropriate for the general public or patients.
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| Austin, TX |
| May 13 |
Wyndham Garden Hotel
3401 S. IH-35
Austin, TX 78741
512-744-4831 |
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| Westerville, OH |
| May 13 |
Standard Process of Ohio
98 Commerce Park Dr
Westerville, OH 43082
614-891-4226
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| Lino Lakes, MN |
| May 19 |
Country Inn & Suites
725 Town Center
Lino Lakes, MN 55014
Please call 763-746-9500 for directions. |
| Click here to view more events... |
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BioMeridian International |
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