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 are recognized leaders in medical device safety, serving top manufacturers worldwide.
**Expertise & scope**
* IEC 60601-1 with national differences (US, Europe, Canada, etc.)
* IEC 60601-1-2 with national differences (US, Europe, Canada, etc.)
* IEC 61010-1 with national differences (US, Europe, Canada, etc.)
* Medical Device and Laboratory Equipment Safety Standards
* Electromagnetic Compatibility (EMC) Evaluation
* Feasibility Studies
* Design & Development Compliance Services
* Preliminary Evaluation and Testing (Pre-Testing)
* Full Medical Device or Laboratory Equipment Evaluation including testing, documentation reviews, and report writing.
* Compliance Services retainer for expert consultation via phone, meetings, and email.
* Seminars for teams on appropriate standards and compliant design/documentation.
**Reputation / proof points**
* Serves top manufacturers worldwide.
Medical Equipment Compliance Associates, Inc. (MECA) is a provider of expert medical and laboratory equipment compliance testing and documentation for global regulatory bodies. They are recognized leaders in medical device safety, serving top manufacturers worldwide.
**Expertise & scope**
* IEC 60601-1 with national differences (US, Europe, Canada, etc.)
* IEC 60601-1-2 with national differences (US, Europe, Canada, etc.)
* IEC 61010-1 with national differences (US, Europe, Canada, etc.)
* Medical Device and Laboratory Equipment Safety Standards
* Electromagnetic Compatibility (EMC) Evaluation
* Feasibility Studies
* Design & Development Compliance Services
* Preliminary Evaluation and Testing (Pre-Testing)
* Full Medical Device or Laboratory Equipment Evaluation including testing, documentation reviews, and report writing.
* Compliance Services retainer for expert consultation via phone, meetings, and email.
* Seminars for teams on appropriate standards and compliant design/documentation.
**Reputation / proof points**
* Serves top manufacturers worldwide.
Additional information
MECA offers several engagement models to address compliance needs. For ongoing questions and expert consultation, a retainer-based Compliance Services model is available in 2, 6, or 12-month options, with time spent via calls, meetings, and emails. For early-stage risk mitigation, Preliminary Evaluations involve a 1-day deep-dive with an engineer to review device construction and documentation before design freeze. Preliminary Testing (Pre-Testing) allows for checking compliance with specific tests from standards like IEC 60601-1, with passing results potentially usable in full evaluations. Full Medical Device or Laboratory Equipment Evaluations result in a completed Test Report Form (TRF). Seminars can be customized for teams to build knowledge on relevant standards.
Key Highlights
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Specializes in IEC 60601-1 and IEC 61010-1 standards, including national differences.
Source
“IEC 60601-1 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 for early identification of compliance issues.
Source
“Having a Preliminary Evaluation conducted before design freeze is a good way to accomplish this.”
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Provides Preliminary Testing (Pre-Testing) to check compliance with specific standard tests.
Source
“Want to check whether the current design or prototype is compliant with certain tests from standards such as IEC 60601-1, IEC 60601-1-2, IEC 61010-1, etc.?”
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Full Medical Device or Laboratory Equipment Evaluations include testing, documentation reviews, 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.”
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Offers 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.”
Certifications & Trust Signals
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Serves top manufacturers worldwide.
Source
“They are leaders in medical device safety, serving top manufacturers worldwide.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking IEC 60601 and IEC 61010 compliance.
- Laboratory equipment manufacturers requiring safety and EMC testing.
- Companies needing expert consultation on compliance standards and interpretations.
How engagement typically works
- Retainer-based consultation (Compliance Services).
- Project-based evaluations and testing.
- Customizable seminars for team training.
Typical deliverables
- Test Report Forms (TRFs).
- Datasheets or Letter Reports from pre-testing.
- Documentation review feedback.
- Seminar content and training.
Good to know
- Best when proactive identification of compliance issues is desired early in the design process.
- Compliance Services retainers are not for full device evaluations.
- No refunds for unused time in Compliance Services retainers.
Pricing
Model:
Custom pricing
Public range:
Publicly listed retainer options: $2,960.00 (2 months), $5,920.00 (6 months), $14,800.00 (12 months).
Notes:
Based on publicly listed information for Compliance Services; final fees for evaluations depend on scope.
“$2,960.00; $5,920.00; $14,800.00”
HQ:
Oak Creek, US
Languages:
English
Timezones:
EST
Claim 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, Both
Test Types Offered
Medical Device Safety Testing, EMC Evaluation
Pricing Model
Retainer, Per project
