Home2019-07-30T16:44:18+00:00

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. We are accredited to ISO 17025, are a Certified Body Testing Laboratory (CBTL) under the IECEE CB Scheme and participate in the UL Data Acceptance Program (DAP), Intertek Recognized Testing Laboratory Program (RTL) and TUV Rhineland NA Partner Testing Laboratory Program (PTL). 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 though 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.

The MECA Process

OUR SERVICES

  • Accredited Compliance Reports
  • CB Test Reports
  • Compliance Engineering Expertise
  • NRTL Certification Marks (through UL, Intertek, or TUV-R)
  • Electrical, Mechanical, Thermal, and Sound/Alarm Testing
  • Training
View All

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.

LEARN MORE >

STEP 2

Testing

Conduct necessary testing to determine compliance with applicable standards.

LEARN MORE >

STEP 3

Documentation

Assess documentation to determine compliance with applicable standards.

LEARN MORE >

STEP 4

Report Writing

Prepare reports using Internationally Recognized Test Report Forms (TRF).

LEARN MORE >

STEP 5

International Options

Issue Reports/Certificates and obtain UL, ETL, TUV-R Safety Certification Marks.

LEARN MORE >

Get Started

Begin the compliance process today by contacting MECA.

Get A Quote

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 ‘60601 series of standards. Our expertise and laboratory accreditations allow us to test a wide variety of devices.

View Devices

MEDICAL EQUIPMENT

Medical Equipment is tested to the IEC 60601-1 series of standards, including Collateral Standards, Particular Standards and National Deviations.

View Requirements

LABORATORY EQUIPMENT

Laboratory Equipment is tested to the IEC 61010-1 series of standards, including Particular Standards and National Deviations.

View Requirements
Get a Quote
Questions?