Guidance & services for testing and documenting compliance to the required medical and laboratory equipment standards Medical equipment standards: IEC 60601-1, national deviations (ES 60601-1, EN 60601-1, CSA C22.2 No. 60601-1, UL 60601-1) Laboratory equipment standards: IEC 61010-1, national deviations (EN 61010-1, CSA C22.2 No. 61010-1, UL 61010-1)
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) are required. These are now harmonized to Edition 3 (and being harmonized with Amendment 1, which is 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 of IEC 60601-1 is 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 to these standards, works with you to address any noncompliances, and documents the compliance in an internationally recognized report format (TRF: Test Report Form). For most standards, this evaluation also includes review of documented processes, such as risk management and usability. 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.
See our Project Process page for more information on the 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, 2013 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. 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.
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 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 compliance needs: Brian Biersach firstname.lastname@example.org (262-347-3436)
Also, see the Contact page for our employee phone numbers, emails, and photos.
Experts in the field of medical certification and regulatory compliance with a commitment to quality service Founded 2002