- 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 their medical certification work Evaluation, Testing, Compliance Reports, Safety Certification 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, 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 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 7 of the Top 10 Medical Manufacturers Worldwide (17 of the Top 40) as clients (per MD&DI - December, 2009 Ranking) LINK to Equipment Evaluation Experience List       SERVICES Medical Equipment Evaluation, Testing, Compliance Informative Test Reports The Least expensive and fastest 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 These Reports are required in your Technical Files to meet FDA and CE Marking requirements  This DOES NOT include a safety (NRTL) Mark(s) - 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 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 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 certification marks - just tell us your needs   Evaluation, Testing, Compliance Reports for FDA 510(k) Submissions, Clinical Trials, and CE Marking (per MDD) Partial and Full Medical Device Evaluation and Testing with a Compliance Informative Test Report, for documentation of compliance to required standards 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 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    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   Variation Notice Resolution Quickly resolve Variation Notices for medical products that arise during quarterly Agency inspections Avoid having your products placed on hold by agency inspectors Avoid future Variation Notices   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 simple questions without charge Design reviews to avoid noncompliances early in the project   PROJECTS Typical Project Process Client Contact (NDA, if needed, equipment  information provided) Project Proposal Sent Agreements Sent  PO# Received Agreements Received Deposit Received (as applicable) PROJECT OPENED  Preliminary Evaluation - Construction Review - Insulation Diagram - Critical Component List - Test List (preliminary) - Noncompliances documented - Manual/Markings Requirements 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   MECA Information and Service Request Page We will not release any information submitted on this form.  It is for quoting and question submission only. We try to answer these within a day, but it may take longer if there is a high workload. Please also feel free to call or email Brian Biersach or Jeremi Peck directly.   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. - 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 - 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) - Electrosurgical (RF) Equipment - Endoscopic Equipment and Accessories - 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 - Lithotriptors   - 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.) - Pacemaker Programmers - Patient Monitors - 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