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Guidance & services for testing and documenting compliance to the required medical and laboratory equipment standards
 Medical equipment standards: IEC 60601-1, published national deviations: US (AAMI ES), Europe (EN), Canada (CSA)
Laboratory equipment standards: IEC 61010-1, published national deviations: US (UL), Europe (EN), Canada (CSA)

MECA Brian Biersach MECA Paula Biersach MECA Jeremi Peck MECA Alex Grob MECA Robert Koch MECA Anna Herzfeld MECA Justin Martineau MECA Paul Dillon MECA Cathi Koch
MECA Mark A2LA ilac Mark MECA IECEE CB Scheme Accredited UL Classified for US, Canada TUV Rheinland Certified for US, Canada Intertek Certified for US, Canada
CE Mark for Europe

 

What We Do

To place a medical device on the market in any country, you need to demonstrate that the device is safe and effective. Using established international standards is the primary way to do this. For all but low risk devices, countries require review of evidence that the device is safe to use before it can be placed on the market. Providing compliance reports to the standards recognized by each country accomplishes this.

For
medical equipment, the IEC 60601-1 standard, as well as the applicable Collaterals, Particulars, and national deviations
(US: AAMI ES 60601-1, Canada: CSA C22.2 No. 60601-1, and The European Union countries: EN 60601-1).
These are now harmonized to Edition 3.1.

Edition 3.1 of IEC 60601-1 (2012) is Edition 3 (2005) with Amendment 1 (2012), and is required by almost all countries in the world.
The only country still requiring the Second Edition China (which requires a report to Edition 2).

For
laboratory equipment, the standard is IEC 61010-1, as well as applicable Particulars and national deviations
(US: UL 61010-1, Canada: CSA C22.2 No. 61010-1, and The European Union countries: EN 61010-1).

MECA evaluates and tests your device, reviews the required documentation to these standards, and works with you to address any noncompliances. The results are documented in the internationally recognized report format (TRF: Test Report Form).
This is the report that you use to get your medical device on the market in every country. The report can also be issued as a
CB Report, under the IECEE CB Scheme, for obtaining multiple safety marks internationally (not required for CE Marking).

All of MECA's services are geared to speed the process of the evaluation and documentation, as well as lowering your overall costs. Each project is customized to provide the fastest possible completion time, at a competitive price, based on the device type and your specific needs.

Our engineers work directly with you.
This  allows you to track the status of your project, as well as work through any noncompliance issues to complete the project.

See our
Project Process page for more information on the project process, and the Services page for all of the services we offer.
 

Trust in a Leader to Meet Your Deadlines

MECA is honoured to service 8 of the Top 10 Medical Manufacturers Worldwide as clients.
(per MD&DI - December, 2014 Ranking)

Our job is to help you to meet your compliance deadlines.
By using our compliance services in the design process and performing a preliminary evaluation before the full evaluation,
we can decrease the time it takes to get through the full compliance process, and get your device to the market.
See the
Project Process page for the project steps of a full evaluation.

Since 2002, MECA has been assembling the top medical equipment compliance specialists in the field, to help our clients meet the required regulatory standards in a time-sensitive and cost-effective manner. This allows our clients to submit to their Notified Bodies,
the FDA, Health Canada, and other international regulatory bodies earlier, and get to market faster.

MECA is known as a technical leader in the field. To assure that we never lose sight of this, we remain active on IEC, AAMI, and ISO medical standards development committees and maintenance teams. With the complexity of the medical device standards, as well as their Collateral and Particular standards, this participation keeps us current with the changing requirements, and allows us to influence the requirements and interpretations of the standards.

Whether you're with a large international device manufacturer or a small start-up company, we're here to help you.


Fully Accredited Lab, So Reports Are Accepted Internationally

MECA is an ISO 17025 accredited testing lab for medical and laboratory equipment
(A2LA Accredited with ilac MRA, as well as the IECEE CB Scheme, UL, TUV Rheinland, and Intertek).
This means our reports are accepted by regulatory bodies world-wide.
See the About/Certs page, for a list of all the accreditations that we maintain.


              PLEASE feel free to email or call me if you have general or specific questions about your device or compliance needs:
              Brian Biersach
bb@60601-1.com (262-347-3436)

Also, see the
Contact page for our employee phone numbers, emails, and photos.

MECA Brian Biersach

Check The
Updates
Recently added information & updates



Medical Standards
Project Scope Tool

FREE Rev. 2015-08-17
Collaterals, Particulars - referenced required standards/requirements
Downloads page


Medical Standards List
FREE Rev. 2015-01-30
Updated list of IEC and National
medical standards

Downloads page


Medical Alarm Standards
Cross-Reference
FREE Rev. (2015-04-01)
Resource for alarm standards
Downloads page


MECA GMSU
Global Medical Standards Update
Revised July, 2015
US FDA, Health Canada, EU OJ, Brazil INMETRO updates for
regulatory standards requirements
Some information is FREE,
some requires a subscription

MECA GMSU page

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- Work With The Experts to Speed Your Device to Market -

Experts in the field of medical certification and regulatory compliance with a commitment to quality service
Founded  2002

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