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IEC 60601-1 Guidance and Services for Medical Equipment Compliance & Certification
Testing and documenting compliance to the required medical and laboratory equipment standards Medical equipment standards: IEC 60601-1 with national deviations: US (AAMI ES), Europe (EN), Canada (CSA) Laboratory equipment standards: IEC 61010-1 with national deviations: US (UL), Europe (EN), Canada (CSA)
What We Do Our job is to help you understand the medical device regulatory requirements so you can design your equipment and prepare your documentation to comply with the required international standards: IEC 60601-1, with national deviations. We also handle laboratory equipment, under the IEC 61010-1 standard, with national deviations.
We then evaluate and test your device, review the required documentation to these standards, and work with you to address any noncompliances. The results are documented in the internationally recognized report format (TRF: IECEE 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. (A CB Report is not required for CE Marking).
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 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).
All of MECA's services are geared to speed the process of getting your device on the market, 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 the Project Process page for the project steps of a full evaluation.
Trust in a Leader to Meet Your Deadlines MECA is honored to service 8 of the Top 10 Medical Manufacturers Worldwide as clients.(per MD&DI - December, 2014 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.
Fully Accredited Lab, So Reports Are Accepted Internationally
US FDA, Health Canada, Brazil, European Union countries, Japan, China, Korea, etc. See full list of accepting countries. 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.
Also, see the Contact page for our employee phone numbers and emails.
PLEASE feel free to email or call me if you have general or specific questions about your device or compliance needs: Brian Biersach email@example.com (262-347-3436)
Experts in the field of medical certification and regulatory compliance with a commitment to quality service Founded 2002