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- Speed Your Medical Equipment to Market -
     
     
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Thank you for visiting MECA's website for the information and
resources you need |
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MECA is based in southeastern Wisconsin, and has assembled the top
medical equipment compliance specialists in the field to provide full
compliance services to our clients in a cost-effective manner.
We are honored to service 6 of the Top 10 Medical Manufacturers
Worldwide (13 of the Top 40) as clients (per
MD&DI - December, 2011 Ranking)
MECA's services are geared to speeding the process of compliance work
and documentation, as well as lowering your overall evaluation costs.
Each project is customized to provide the fastest completion at the
least cost, based on the device type and the client's specific needs.
• Medical Device Evaluation, Testing, Compliance Reports, for:
- FDA 510(k), PMA,
Clinical Trials
- CE Marking (under the MDD)
- Compliance Documentation
for International Marketing
• Obtaining Third Party Safety Marks (UL, TUV, etc.), for:
- Selling to Hospitals,
Clinics, Institutions, and other Organizations who Require an NRTL
Safety Mark
• Compliance Engineering Services, for:
- Assuring the device
design complies with the applicable standard requirements
- Reduce the cost of
redesign by identifying noncompliances early in the design process
• Custom Testing of Medical Devices
- Sound and Alarm Testing,
Using ISO 3744 Hemi-Anechoic (Free Field) Sound Chamber (for alarms,
audible signals, and device sound level measurements)
- Cleaning and
Disinfection Testing (accelerated life testing of
cleaning/disinfectant agents specified in user manuals)
- Electrical &
Mechanical Testing, per Client's Needs
See the SERVICES page for a detailed list
of all the services offered, as well as a list of devices that we
have evaluated.
MECA Experience and Expertise
• CB Testing Laboratory, under the IECEE CB Scheme for
medical equipment (ACTL)
• UL Third Party Test Data Program for medical devices
• TUV Rheinland Qualified Laboratory for medical devices
• ISO 17025 and ISO 9000 compliant quality system for
testing labs
• US Technical Experts for AAMI on IEC/ISO Working
Group Committees for international medical device standards
(writing/maintenance of the medical standards)
See the ABOUT MECA page for
Certifications and employee biographies
PLEASE feel free to email us if you have general or specific questions.
For quickest response, use info@60601-1.com
See the CONTACT page for employee photos,
phone numbers, and emails
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Why do you need to meet the UL60601-1 / IEC60601-1 / EN60601-1 /
CSA C22.2 No. 601.1 safety standards ? |
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- The FDA requires safety performance testing.
IEC 60601-1 + US deviations (UL 60601-1) is
the key FDA recognized consensus standard for medical electrical equipment.
Without a Compliance Report, you will not be
able to establish that you meet these required standards
- In the US, the Occupational Safety and Health
Administration (OSHA) requires a safety mark from a National
Recognized Testing Laboratory (NRTL) for use in a public facility.
This is specified in OSHA Standards Part
1910, Subpart S-Electrical, Sec. 1910.399.
*this requirement is rarely enforced (for
now) in the US
(NRTLs include UL, TUV Rheinland, TUV
SUD/Product Service, CSA, Intertek/ETL, and others)
- Most Local AHJs (Authorities Having Jurisdiction) and
nearly all hospitals and clinics in the US require 3rd party safety
marks on equipment to be purchased.
These safety marks rely on compliance with
the UL 60601-1 standard in the US.
- The CE Mark is required on a product to place it
on the market in the European Union.
For medical equipment, the CE Marking
requirements are in the MDD (Medical Device Directive), which is
European Law.
- The MDD requires documentation of compliance to
the applicable safety standards (such as EN 60601-1).
You may not legally place a medical device
on the market in the European Union without meeting the Medical
Device Directive requirements.
For all medical equipment, except (per MDD)
Class 1, non-measuring, non-sterile, an Audit by a Notified Body
(from Europe) is required before the CE Mark may be placed on a
medical device.
The CE Mark will have a 4-digit number
under it, denoting the Notified Body used.
- By meeting the requirements of the IEC60601-1
series of standards with National Deviations, you officially meet the
requirements of most of the world's nations, and unofficially meet
the requirements of all.
This opens your marketing potential to the
entire world market.
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If you have suggestions for this website or information that you
would like to see, please let us know at info@60601-1.com
Much of the information presented on this website came from questions
and suggestions from our clients and visitors to this site.
We would love to hear from you!
Thank you,
Brian R. Biersach
President, Sr. Biomedical Engineer
MECA
Medical Equipment Compliance Associates, LLC
5060 W. Ashland Way
Franklin, WI 53132 USA
Email: bb@60601-1.com
Phone: 262-752-4017 x101
eFax: 847-919-3512
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