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- Speed Your Medical Equipment to Market -

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Guidance & services for documenting compliance to the required medical and laboratory equipment standards
 Medical equipment standards: IEC 60601-1, AAMI ES 60601-1, EN 60601-1, CSA C22.2 No. 60601-1, UL 60601-1
Laboratory equipment standards: IEC 61010-1, EN 61010-1, CSA C22.2 No. 61010-1, UL 61010-1

MECA Brian Biersach MECA Paula Biersach MECA Jeremi Peck MECA Alex Grob MECA Robert Koch MECA Anna Herzfeld MECA Paul Dillon MECA Cathi Koch MECA UL Third Party Test Data Program MECA Intertek Recognized Testing Laboratory MECA TUV Rheinland Qualified Laboratory MECA IECEE CB Scheme Accredited MECA Mark MECA Justin Martineau MECA Angus Frey MECA Chad Peronto

 

Trust in a Leader to Meet Your Deadlines

 
MECA is honored to service 8 of the Top 10 Medical Manufacturers Worldwide (18 of the Top 40) as clients, per MD&DI - December, 2013 Ranking.

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.


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.

The IEC 60601-1, AAMI ES 60601-1, CSA C22.2 No. 60601-1, and EN 60601-1 standards are now harmonized to Edition 3.1.
Edition 3.1 (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 of IEC 60601-1 is China, which requires documentation to Edition 2.

For laboratory equipment, the international standards are the IEC 61010-1, EN 61010-1, CSA C22.2 No. 61010-1, UL 61010-1.

MECA evaluates and tests your device to these standards, works with you to address any noncompliances, and documents the compliance in an internationally recognized report format (TRF). For most standards, this evaluation includes review of documented processes, such as risk management and usability. We can also issue the report as a CB Report, under the IECEE CB Scheme.

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.

We look forward to helping you meet your deadlines.

See our
Services Page for more information on all of the services we offer:
Accredited Compliance Reports
CB Reports
Limited Evaluations, with Letter Reports
NRTL Safety Marks for the US and Canada
Compliance Services
Custom Testing
Training and Seminars
 

PLEASE feel free to email us if you have general or specific questions about your compliance needs.
See the
Contact page for employee phone numbers, emails, and photos.

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