What We Do
MECA provides high-quality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the IEC 60601-1 and IEC 61010-1 series of standards. Most often, this documentation is used to submit to global regulatory bodies.
MECA is also involved directly in the Standards Development Process as technical experts on various IEC and AAMI standards development committees.
STREAMLINED PROCESS
The process of obtaining evidence of compliance to global standards can be difficult, time consuming and frustrating. At MECA, our goal is to help you through this process as efficiently as possible, putting our expertise at your disposal to reduce surprises and resolve issues quickly and effectively. Partner with us for a better experience.
OUR SERVICES
- Accredited Compliance Reports for Safety and EMC
- CB Test Reports for Safety
- Compliance Engineering Expertise for Safety and EMC
- NRTL Certification Marks (through UL or SGS) for Safety
- Electrical, Mechanical, Thermal, EMC and Sound/Alarm Testing
- Training
WHY CHOOSE MECA
Committed Partner in Safety
MECA sustains global leadership in medical device safety through our vast knowledge and experience.
SERVING THE BEST
MECA is honored to service 8 of the Top 10 Medical Manufacturers Worldwide as clients.
TOP SPECIALISTS
Since 2002, MECA has been assembling the top medical equipment compliance specialists in the field.
INDUSTRY EXPERTS
Our engineers are engaged directly in the global standards development & application process (IEC, ISO, AAMI, IECEE).
FAST & EFFICIENT
Switch to MECA and learn how our knowledge and partnerships with our clients help them reach their goals in a timely manner.
ACCREDITED
MECA is an ISO 17025 accredited testing lab for medical and laboratory equipment.
INTERNATIONAL
Our accreditations help facilitate global acceptance of your device.
Our Compliance Process
Our goal is to help you obtain the necessary safety documentation required to assist you in getting your medical device or laboratory equipment on the market.
STEP 1
Preliminary Evaluation
Evaluate the device against the requirements of applicable standards.
STEP 2
STEP 3
STEP 4
Report Writing
Prepare reports using Internationally Recognized Test Report Forms (TRF).
STEP 5
Certification Options
Issue Reports/Certificates and obtain Safety Certification Marks.
Get Started
Begin the compliance process today by contacting MECA.
BE PREPARED
Market Requirements
To place a medical device on the market in nearly all countries, you need to demonstrate to regulatory bodies that the device is safe and effective. Test reports documenting compliance with applicable international standards is often the best way to accomplish this.
MECA specializes in evaluating to the IEC-60601-1 series of standards. Our expertise and laboratory accreditations allow us to test a wide variety of devices.
MEDICAL EQUIPMENT
Medical Equipment is tested to the IEC 60601-1 series of standards, including Collateral Standards, Particular Standards and National Deviations.
LABORATORY EQUIPMENT
Laboratory Equipment is tested to the IEC 61010-1 series of standards, including Particular Standards and National Deviations.