- Speed Your Medical Equipment to Market - Thank you for visiting MECA's website for the information and resources you need * Compliance Reports for the Third Edition of IEC/EN 60601-1, to demonstrate compliance to your Notified Body for Europe (see the SERVICES page for a full list of services)   MECA is based in southeastern Wisconsin, and has assembled the top medical equipment compliance specialists in the field to provide full compliance services to our clients in a cost-effective manner. We are honored to service 6 of the Top 10 Medical Manufacturers Worldwide (13 of the Top 40) as clients (per MD&DI - December, 2011 Ranking) MECA's services are geared to speeding the process of compliance work and documentation, as well as lowering your overall evaluation costs. Each project is customized to provide the fastest completion at the least cost, based on the device type and the client's specific needs.   • Medical Device Evaluation, Testing, Compliance Reports, for:         - FDA 510(k), PMA, Clinical Trials         - CE Marking, under the MDD (EN 60601-1, Third Edition)         - Compliance Documentation for International Marketing   • Obtaining Third Party Safety Marks (UL, TUV, etc.), for:         - Selling to Hospitals, Clinics, Institutions, and other Organizations that Require an NRTL Safety Mark   • Compliance Engineering Services, for:         - Assuring your device or design complies with the applicable standard requirements         - Reduce the cost of redesign by identifying noncompliances early in the design process   • Custom Testing of Medical Devices         - Sound and Alarm Testing, Using ISO 3744 Hemi-Anechoic (Free Field) Sound Chamber (for alarms, audible signals, and device sound level measurements)         - Cleaning and Disinfection Testing (accelerated life testing of cleaning/disinfectant agents specified in user manuals)         - Electrical & Mechanical Testing, per Client's Needs See the SERVICES page for a detailed list of all the services offered, as well as a list of devices that we have evaluated. MECA Experience and Expertise   • CB Testing Laboratory, under the IECEE CB Scheme for medical equipment (ACTL)   • UL Third Party Test Data Program for medical devices   • TUV Rheinland Qualified Laboratory for medical devices   • ISO 17025 and ISO 9000 compliant quality system for testing labs   • US Technical Experts for AAMI on IEC/ISO Working Group Committees for international medical device standards (writing/maintenance of the medical standards) See the ABOUT MECA page for Certifications and employee biographies PLEASE feel free to email us if you have general or specific questions. For quickest response, use info@60601-1.com See the CONTACT page for employee photos, phone numbers, and emails     Why do you need to meet the IEC/UL/ES/CSA/EN 60601-1 standards ?   - The FDA requires safety performance testing.      IEC 60601-1 is the key FDA recognized consensus standard for medical electrical equipment (with US Deviations).      Without a Compliance Report, you will not be able to establish that you meet these required standards   - In the US, the Occupational Safety and Health Administration (OSHA) requires a safety mark from a National Recognized Testing Laboratory (NRTL) for use in a public facility.       This is specified in OSHA Standards Part 1910, Subpart S-Electrical, Sec. 1910.399.       *this requirement is rarely enforced (for now) in the US      (NRTLs include UL, TUV Rheinland, TUV SUD, CSA, Intertek/ETL, and others)   - Most Local AHJs (Authorities Having Jurisdiction) and nearly all hospitals and clinics in the US require 3rd party safety marks on equipment to be purchased.      These safety marks rely on compliance with the UL 60601-1 standard in the US.   - The CE Mark is required on a product to place it on the market in the European Union.      For medical equipment, the CE Marking requirements are in the MDD (Medical Device Directive), which is European Law.   - The MDD requires documentation of compliance to the applicable safety standards (such as EN 60601-1).       You may not legally place a medical device on the market in the European Union without meeting the Medical Device Directive requirements.      For all medical equipment, except (per MDD) Class 1, non-measuring, non-sterile, an Audit by a Notified Body (from Europe) is required before the CE Mark may be placed on a medical device.      The CE Mark will have a 4-digit number under it, denoting the Notified Body used.   - By meeting the requirements of the IEC60601-1 series of standards with National Deviations, you officially meet the requirements of most of the world's nations, and unofficially meet the requirements of all.      This opens your marketing potential to the entire world market.   If you have suggestions for this website or information that you would like to see, please let us know at info@60601-1.com Much of the information presented on this website came from questions and suggestions from our clients and visitors to this site.  We would love to hear from you!   Thank you, Brian R. Biersach President, Sr. Biomedical Engineer  MECA Medical Equipment Compliance Associates, LLC 5060 W. Ashland Way Franklin, WI  53132 USA Email:  bb@60601-1.com Phone: 262-752-4017 x101 eFax:   847-919-3512