- Speed Your Medical Equipment to Market - Why are more medical equipment companies choosing MECA for their Certification and Regulatory work? We offer Certification Outsourcing services to clients who choose to outsource part or all of the certification work Medical Equipment Compliance Evaluation and Testing to Medical Reference Standards We specialize in medical equipment, so we stay current with the medical standards and interpretations                         We Serve as a US Experts for AAMI on IEC-ISO Working Groups for medical standards writing committees We handle UL Classification, CSA and TUV Certification, and other certification processes from start to finish We provide training and compliance engineering services, certification, and testing for your medical products We have a network of Associates who are leaders in their respective fields to assist with your needs We are here to answer your questions and assist in current and future products and product changes You receive the time and cost savings Medical Equipment Compliance Associates 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 5 of the Top 10 Medical Manufacturers Worldwide (14 of the Top 40) as clients (per MD&DI - December, 2007 Ranking) LINK to Equipment Evaluation Experience List       SERVICES Medical Equipment Evaluation, Testing, Compliance Informative Test Reports Least expensive path to demonstrating compliance to required standards Evaluation, Testing, and CIT Reports (Compliance Informative Test Reports) for Medical Electrical Equipment The Compliance Informative Test Reports demonstrate compliance to the applicable IEC, UL, CSA, EN, ISO, and AAMI standards Required in your Technical Files to meet FDA and CE Marking requirements  This DOES NOT include a safety (NRTL) Mark - See below for Classification and Certification services   UL  Classification , TUV Certification ,  CSA Certification , and other Medical Safety Certifications Certification with Quick Turnaround MECA is under the UL Third Party Test Data Program, specializing in the evaluation and testing of medical equipment By performing preliminary evaluations, providing compliance services, testing at MECA's laboratory, and writing of the Compliance Informative Test Reports, we can decrease the time to obtain safety certification We also provide services for obtaining other International safety marks - just tell us your needs       Typical Process:           Preliminary Evaluation           - Construction review           - Create Insulation Diagram           - Identify the critical components and verify that they meet the requirements in the standards (spacings, ratings, etc.)           - Determine the applicable tests that will be conducted           - Perform preliminary tests to help identify potential problems, as necessary           - Address any non-compliances in construction or testing, and work with our client's design team to resolve them           Compliance Evaluation           - Conduct Initial Review with Certification Agency           - Conduct the required testing at MECA's Lab           - Review Accompanying Documents and Equipment Labels           - Write the Compliance Informative Test Report, covering all the standards requirements for your equipment           - Submit the completed reports to Certification Agency (UL, TUV Rhineland, CSA, or other Agency) for final review           - After a successful final review, the Client receives a letter of authorization to apply the applicable safety Mark from the Certification Agency           - The Client receives the final Report once it has been published in it's final form by the Agency           (Throughout the process, our clients and the responsible UL/TUV/CSA engineers and reviewer are kept informed of the details and progress )   Medical Device Construction Changes Construction changes often require revisions to your Certification Report (UL, TUV, CSA, etc.), and may require testing MECA can determine whether retesting and/or report revisions are necessary The process can be as simple as a phone discussion or may be as complex as the full evaluation process given above, depending on the compliance implications of the changes   Variation Notice Resolution Quickly resolve Variation Notices for UL 60601-1 (UL 2601-1), UL 544, and UL 187 products that arise during quarterly Agency inspections Avoid having your products placed on hold by the inspectors Avoid future Variation Notices   UL 544 and UL 187 to UL 60601-1 Transition Avoid the last-minute rush and bring your UL 544 and UL 187 equipment into compliance with the new standards now If your medical and dental equipment was evaluated to UL 544, it will have a UL Listing Mark If your X-Ray equipment was evaluated to UL 187, it will have a UL Classification Mark and state "UL 187" UL 544 and UL 187 equipment UL Reports are all "locked", and require re-evaluation to UL 60601-1 if anything is changed (critical components or typos) This  includes components in your reports that may be a Typo or considered non-safety critical   Training and Seminars The training and seminars will provide you with the information you need to  meet the UL 60601-1, IEC 60601-1, EN 60601-1, and CSA C22.2 No. 601.1 safety standards, as well as the IEC 60601-X-XX Collateral and Particular Standards Learn to design your medical equipment to meet the construction and testing requirements of the standards Training and Seminar information is available on our Seminar/Training Page   Compliance Engineering Services  Quick answers to your compliance questions - just call. We can answer most questions without charge Design reviews to avoid noncompliances early in the project   Evaluations/Testing for FDA 510(k) Submissions and Clinical Trials Partial and Full Medical Device Evaluation and Testing, with an Informative Test Report for documentation of compliance to reference standards Assure that you meet the FDA requirements for compliance to the specified reference standards We can also provide FDA submission assistance with our Associates FDA 510(k) submissions Repair and re-filing of deficient 510(k) submissions Coordinating 3rd Party 510(k) reviews to speed the FDA review process   CE Marking Assistance  Compliance with the Medical Device Directive (MDD) requirements  We work with many Notified Bodies to get you your equipment authorized for CE Marking for Class I, IIa, IIb, and III medical devices (per the MDD) To legally market your equipment in the European Union, you must meet the Essential Requirements in the Medical Device Directive (MDD) For any medical device (except Class I, non-measuring, non-sterile devices), you must use a Notified Body, and provide the NB number under the CE Mark    MECA Information and Service Request Page We will not release any information submitted on this form.  It is for quoting purposes only. You can trust Medical Equipment Compliance Associates with your certification and regulatory compliance needs.   Equipment Evaluation Experience List  The following is a list of equipment that we have experience evaluating to the '60601 medical standards. Don't see your equipment listed here? We evaluate new types of medical equipment all of the time. - Alarms for Medical Equipment - Ambulatory Electrocardiographic Monitors (Holter Monitors) - Anesthetic Machines - Artificial Hearts (Externally Powered) - Automatic Cycling Indirect Blood Pressure Monitors - Baby Incubators - Blankets, Pads and Mattresses for Heating in Medical Use - Blood Glucose Meters and Accessories - Cardiac Defibrillators - Cardiac Pumps - Cooling Equipment (Patient Coolers) - Defibrillators (Conventional, AED: Advisory External Defibrillator)  - Dental Chairs - Dental Drills - Dermatomes - Diagnostic and Therapeutic Lasers - Diagnostic Tables - Diagnostic X-ray Generators - Direct Blood Pressure Monitors - Electrocardiographs (ECG EKG) - Electroencephalographs (EEG) - Electromyographs (EMG) - Endoscopic Equipment - Exam Tables - Extracorporeally and Internally Induced Lithotriptors - Fluid Pumps for Medical Use - Gamma Cameras (PET Systems) - Headwalls for Medical Use - Hemodialysis Equipment - High Frequency Surgical Equipment - Hospital Beds - Imaging Equipment - Infant Radiant Warmers - Infusion Pumps - Light Treatment Equipment for Medical Use - Lung Ventilators   - LASER Medical Devices - LVADs (Left Ventricular Assist Devices) - Magnetic Resonance Imaging Equipment (MRI) - Mammographic Stereotactic Devices - Mammographic X-ray Equipment - Medical Stretchers - Medical Monitors (computer monitors for medical) - MRI Coils - Multiparameter Patient Monitoring Equipment       (ECG, SPO2, NIBP, Direct BP, CO2, Temp, CO, etc.) - Muscle Stimulators - Nerve Stimulators - Operating Tables - Ophthalmological Equipment (Slit Lamps, etc.) - Perfusion Equipment (Heart Bypass) - PET Scanners - Pulse Oximeters - Recording and Analyzing Electrocardiographs - Remote Controlled Automatically Driven Gamma Ray Afterloaders - Respiratory Gas Monitoring Equipment - Robotic Surgical Equipment - Luminaires (Surgical and for Diagnosis) - Telemitry Systems - Thermometers for Medical Use - Transcutaneous Partial Pressure Monitors - Treadmills for Medical Use - Treatment Tables - Ultrasonic Medical Diagnostic and Monitoring Equipment - Ultrasonic Therapy Equipment - Veterinary Medical Equipment - Warming Equipment (Patient Warmers) - X-Ray Equipment for Computed Tomography - X-Ray Source Assemblies for Medical Diagnosis - X-Ray Tube Assemblies for Medical Diagnosis