Medical Equipment Compliance Associates, Inc.
MECA provides expert medical and laboratory equipment compliance testing and documentation for global regulatory bodies. They are leaders in medical device safety, serving top manufacturers worldwide.
Medical Equipment Compliance Associates, Inc. (MECA) specializes in providing high-quality testing and documentation to ensure compliance with medical and laboratory equipment standards, primarily IEC 60601-1 and IEC 61010-1. Their services are crucial for submitting documentation to global regulatory bodies. MECA actively participates in the Standards Development Process as technical experts on various IEC and AAMI committees, ensuring they are at the forefront of compliance knowledge. MECA aims to streamline the often difficult and time-consuming process of obtaining evidence of compliance. They leverage their expertise to minimize surprises and resolve issues efficiently. The company boasts a strong track record, servicing 8 of the Top 10 Medical Manufacturers Worldwide since 2002. Their engineers are directly involved in global standards development and application processes, including IEC, ISO, AAMI, and IECEE. Services offered include Preliminary Evaluation, Preliminary Testing, Medical Device or Laboratory Equipment Evaluation, Electromagnetic Compatibility (EMC) Evaluation, Wireless Global Access, and FDA ASCA Program support. They also offer Compliance Services as a retainer for expert consultation, and Seminars to equip teams with knowledge of appropriate standards. MECA helps clients reduce costs and time by identifying potential compliance issues early in the design process.
About
**Who they are**
Medical Equipment Compliance Associates, Inc. (MECA) is a provider of expert medical and laboratory equipment compliance testing and documentation for global regulatory bodies. They serve top manufacturers worldwide.
**Expertise & scope**
* Testing and documentation for compliance with medical device and laboratory equipment safety standards, including IEC 60601-1 and IEC 61010-1 series, with national differences (e.g., US AAMI ES, Europe EN, Canada CSA).
* Electromagnetic Compatibility (EMC) evaluation for medical devices and laboratory equipment.
* Services include feasibility studies, design and development support, preliminary evaluations, preliminary testing (pre-testing), and full device evaluations.
* Compliance services offered on a retainer basis for expert consultation via phone, meetings, and email.
* Seminars available to educate teams on appropriate standards and compliant design/documentation.
**Reputation / proof points**
* Experience evaluating devices to IEC 60601-1 and IEC 61010-1 series of standards.
Medical Equipment Compliance Associates, Inc. (MECA) is a provider of expert medical and laboratory equipment compliance testing and documentation for global regulatory bodies. They serve top manufacturers worldwide.
**Expertise & scope**
* Testing and documentation for compliance with medical device and laboratory equipment safety standards, including IEC 60601-1 and IEC 61010-1 series, with national differences (e.g., US AAMI ES, Europe EN, Canada CSA).
* Electromagnetic Compatibility (EMC) evaluation for medical devices and laboratory equipment.
* Services include feasibility studies, design and development support, preliminary evaluations, preliminary testing (pre-testing), and full device evaluations.
* Compliance services offered on a retainer basis for expert consultation via phone, meetings, and email.
* Seminars available to educate teams on appropriate standards and compliant design/documentation.
**Reputation / proof points**
* Experience evaluating devices to IEC 60601-1 and IEC 61010-1 series of standards.
Additional information
MECA offers several engagement models for compliance support. Their 'Compliance Services' function as a retainer, providing access to engineers for standards interpretation and questions over a selected timeframe (2, 6, or 12 months). This service is ideal for addressing specific queries rather than full device evaluations. For immediate assistance with compliance questions, they offer an 'Activate Compliance Services' option, with initial consultations potentially free for new clients. Preliminary evaluations involve a one-day deep-dive into device construction and available documentation to identify potential issues early in the design process. Preliminary testing allows for checking prototype compliance against specific tests from standards like IEC 60601-1, with passing results potentially usable in full evaluations.
Key Highlights
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Expertise in IEC 60601-1 and IEC 61010-1 series standards, including national differences.
Source
“IEC 60601-1 with national differences: e.g. US (AAMI ES), Europe (EN), Canada (CSA), etc. IEC 60601-1-2 with national differences: e.g. US (AAMI ES), Europe (EN), Canada (CSA), etc. IEC 61010-1 with national differences: e.g. US (UL), Europe (EN), Canada (CSA), etc.”
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Offers preliminary evaluations and testing to identify compliance issues early in the design process.
Source
“Having a Preliminary Evaluation conducted before design freeze is a good way to accomplish this.”
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Provides retainer-based compliance services for ongoing expert consultation.
Source
“Compliance services acts as a retainer for the selected timeframe (2 months, 6 months or 12 months) which can be used to ask any standards or compliance-related questions.”
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Conducts full medical device and laboratory equipment evaluations, including testing and report writing.
Source
“A Medical Device or Laboratory Equipment Evaluation includes review of compliance to standards such as IEC 60601-1, IEC 61010-1, etc. including testing, documentation reviews, and report writing.”
Certifications & Trust Signals
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Experience evaluating devices to IEC 60601-1 and IEC 61010-1 series of standards.
Source
“Learn more about some of the devices that MECA has evaluated to the IEC 60601-1 and IEC 61010-1 series of standards.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking compliance testing and documentation.
- Laboratory equipment manufacturers requiring safety standard evaluations.
- Companies needing expert consultation on regulatory standards.
How engagement typically works
- Project-based evaluations.
- Retainer-based consultation services.
- On-demand expert advice.
Typical deliverables
- Test Report Forms (TRFs).
- Datasheets or Letter Reports from pre-testing.
- Documentation reviews.
- Compliance consultation.
Good to know
- Compliance services retainer cannot be used for full device evaluations.
- No refunds provided for unused time on retainer services.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $0.00 - $13,200.00
Notes:
Based on publicly listed information for compliance services retainers and initial free consultations; final fees depend on scope.
“$2,640.00; $5,280.00; $13,200.00; $0.00; $0.00”
HQ:
Oak Creek, US
Languages:
English
Status:
listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
United States
Industries:
Medical Devices
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1, IEC 60601-1-2, IEC 61010-1
Test Coverage:
Both
Nrtl Relationships:
UL, CSA
Wireless Add On Capability:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions
Regions Served:
US, Europe, Canada
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601-1, IEC 60601-1-2, IEC 61010-1
Test Coverage
Safety, EMC
Test Types Offered
Preliminary Testing, EMC Evaluation, Safety Evaluation
Pricing Model
Retainer, Per project
