- Speed Your Medical Equipment to Market - Why are more medical equipment companies choosing MECA for their Certification and Regulatory work? We only work with medical equipment, so we stay current with the constantly changing medical standards and interpretations We offer outsourcing services to clients who choose to outsource part or all of their medical certification work We Serve as a US Experts on IEC, ISO, and AAMI Working Groups for medical standards writing committees We handle UL Classification, TUV Certification, and other NRTL certification from start to finish We provide training and compliance engineering services to assist you in your design We have a network of Associates who are leaders in their respective fields to assist with all your compliance 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 THIS PAGE: LIST OF SERVICES TYPICAL PROJECT PROCESS MEDICAL DEVICE EXPERIENCE LIST       SERVICES Medical Equipment Evaluation, Testing, Compliance Reports for FDA, Notified Bodies (per MDD), and Other International Agencies The Least expensive and fastest path to demonstrating compliance to required standards Evaluation, Testing, and Compliance Reports for Medical Electrical Equipment The Compliance Reports demonstrate compliance to the applicable IEC, UL, CSA, EN, ISO, and AAMI standards These Reports are required in your Technical Files to meet FDA and CE Marking requirements  Assure that you meet the FDA requirements for compliance to the specified FDA recognized standards We can also provide FDA submission assistance with our Associates FDA 510(k) submissions Coordinating 3rd Party 510(k) reviews to speed the FDA review process Compliance with the Medical Device Directive (MDD) requirements for CE Marking in Europe We work with many Notified Bodies to provide compliance reports for CE Marking 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  This DOES NOT include a safety (NRTL) Mark(s) - See below for Classification and Certification services UL  Classification , TUV Certification ,  and other Medical Safety Certifications Certification with Quick Turnaround MECA is under the UL Third Party Test Data Program and the TUV Partner Test Laboratory Program, specializing in the evaluation and testing of medical equipment MECA is an ACTL (Associated CB Scheme Testing Laboratory), for medical standards, under the IECEE CB Scheme 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 The agencies review the reports that we generate, and after any review comments are addressed, they issue the authorization to apply the applicable Safety Mark We also provide services for obtaining other International safety certification marks - just tell us your needs   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 a full evaluation process, depending on the compliance implications of the changes Custom Testing 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)  Special or Limited electrical/mechanical Testing, per Client's Needs Compliance Engineering Services Answers to your compliance questions. Design reviews to avoid noncompliances early in the project We offer Compliance Services with a 4 hr minimum project time. The 2012 hourly rate is $220/hr. PROJECTS Typical Project Process Client Contact (NDA completed if needed) Equipment  information provided (Intended use, general construction) Project Proposal generated and sent Agreements sent  PO# received Agreements received Deposit received (as applicable) PROJECT OPENED  Preliminary Evaluation - Construction review - Insulation Diagram - Critical Component list started - Test List (preliminary) - Noncompliances documented - Manual/Markings requirements reviewed Documentation received (Manual, Markings) Manual and Label review  Production equivalent samples received for testing Confirm samples operational Test Data Package created Equipment testing conducted Address noncompliances Retesting, as required Report writing - Clauses - Test Data - Critical Components - Photos - National Deviations - Collaterals: - Particulars: - Attachments: Report Final Review (MECA, UL, TUV, CSA, etc.) Address Final Review comments Report to client (as applicable, authorization to apply the Agency safety mark) PROJECT COMPLETE   To submit a quote request, please use the QUOTE page.   Equipment Evaluation Experience List The following is a list of equipment that we have experience evaluating to the '60601 and other medical standards. Don't see your equipment listed here? We evaluate new types of medical equipment all of the time. * Note, we do not handle the evaluation of wheel chairs (manual or electrical). Due to confidentiality requirements of some clients, we can not specify manufacturer's devices specifically - Alarms for Medical Equipment - Ambulatory Electrocardiographic Monitors (Holter Monitors) - Anesthetic Machines - Artificial Hearts (Externally Powered or controlled) - Automatic Cycling Indirect Blood Pressure Monitors - Baby Incubators - Biopsy Devices (breast, brain, etc.) - Blankets, Pads and Mattresses for Heating in Medical Use - Blood Glucose Meters and Accessories - Blood Warmers - Cardiac Ablation Devices - Cardiac Defibrillators - Cardiac Pumps - Cooling Equipment (Patient Coolers) - Defibrillators (Conventional, AED)  - 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) - Electrosurgical (RF) Equipment - Endoscopic Equipment and Accessories - Exam Tables - Extracorporeally and Internally Induced Lithotriptors - Fluid Pumps for Medical Use - Fluid Warmers - Gamma Cameras (PET Systems) - Headwalls for Medical Use - Hemodialysis Equipment - High Frequency Surgical Equipment - Hospital Beds - Imaging Equipment - Infant Radiant Warmers - Infusion Pumps (volumetric, syringe, insulin) - Light Treatment Equipment for Medical Use   - Lithotriptors - Lung Ventilators - LASER Medical Devices - LVADs (Left Ventricular Assist Devices) - Magnetic Resonance Imaging Equipment (MRI) - Magnetic Resonance Imaging Coils (head, wrist, breast, etc.) - Mammographic Stereotactic Devices - Mammographic X-ray Equipment - Medical Stretchers - Medical Monitors (computer monitors for medical) - Multiparameter Patient Monitoring Equipment       (ECG, SPO2, NIBP, Direct BP, CO2, Temp, CO, etc.) - Muscle Stimulators - Nerve Stimulators - Operating Tables - Ophthalmological Equipment (Slit Lamps, etc.) - Pacemaker Programmers - Patient Monitors - Patient Movement Devices - 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 - Stretchers - Luminaires (Surgical and for Diagnosis) - Telemetry 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