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.
Over the past decade, MECA has assembled the top medical equipment compliance specialists in the field, to help our clients meet the required standards in a time-sensitive and cost-effective manner. This allows our clients to get submit to their Notified Bodies,
the FDA, Health Canada, and other international regulatory bodies earlier, and get on the 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.
Whether you are with an international manufacturer or a 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 required documentation back from Edition 3.1.
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 some standards, this evaluation includes review of documented processes, such as risk management and usability.
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 completion time, at a competitive price, based on the device type and your specific needs.
See our Services Page for more information on all of the services we offer:
Accredited Compliance Reports
Limited Evaluations, with Letter Reports
NRTL Safety Marks for the US and Canada
Training and Seminars
PLEASE feel free to email us if you have general or specific questions.
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Experts in the field of medical certification and regulatory compliance with a commitment to quality service