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For answers to your questions.
Speak with Brian Biersach at:
Medical Equipment Compliance
Certification and Regulatory
Information & Services
MECA Help Site
Seminar Sept. 14-16
Medical Equipment Compliance Associates, LLC
Testing and documenting compliance to the required medical and laboratory equipment standards
Medical equipment standards: IEC 60601-1 with national deviations: US (AAMI ES), Europe (EN), Canada (CSA)
Laboratory equipment standards: IEC 61010-1 with national deviations: US (UL), Europe (EN), Canada (CSA)
What We Do
Our job is to help you get your medical device or laboratory equipment on the market quickly.
The process of getting your evidence of compliance to the required standards has been difficult, time consuming, and frustrating.
We’ve established a new process, and it’s all about helping you get into compliance and through the regulatory process.
For US FDA 510(k) and PMA, European CE Marking, Health Canada, China CFDA, Japan, Australia, Brazil, and all other countries.
We work with you to address any construction, testing, and documentation noncompliances from start to finish.
No more sending your device to the test lab, waiting for your Dear John letter of failures, and repeating.
This is the new compliance process.
PRELIMINARY EVALUATION (may be conducted as separate Project)
- Review intended use, accessories, interconnections, classifications
- Review and determine applicable standards and project scope (IEC 60601 or IEC 61010 standards)
- Construction evaluation, per standard(s) requirements
- Electrical Insulation diagram generated
- Critical Components reviewed for requirements
- Create applicable tests list
- User manual and device markings requirements reviewed
- Requirements for risk management, software, and usability reviewed
* MECA works with Client addresses any initial noncompliances
TESTING (after any initial noncompliances addressed)
- Verify production equivalent samples received and operational
- Take photographs of device/system and components for report
- Testing base standard (IEC 60601-1 for Medical electrical equipment or IEC 61010-1 for Laboratory equipment)
- Testing applicable Collateral Standards
- Testing applicable Particular Standards
- Testing National Differences
* MECA works with Client to addresses any testing noncompliances
- Conduct retesting, as needed
- Review Risk Management process documentation
- Review Risk Management file (device-specific) documentation
- Review user manual and device markings for requirements
- Review software documentation, if applicable
- Review usability documentation, if applicable
* MECA works with Client to addresses any documentation and markings noncompliances
Write Compliance Report (in the international IECEE CB Scheme TRF format)
- Complete clause verdicts and remarks
- Complete risk management tables (form reviewed guidance document)
- Complete test data tables (from test data package)
- Complete critical components table
(any component that could affect test results or compliance with the standard requirements)
- Complete applicable National Deviations
- Complete Collateral Standards report(s), as applicable
- Complete Particular Standards report(s), as applicable
- Attach insulation diagram, markings, photos, manual, applicable drawings, and applicable schematics
- Addresses any review comments
MECA sends client final report/certificate
(OPTIONAL) US, CANADA NRTL SAFETY MARK AND CB REPORT PROJECTS
Agency project opened (UL, TUV Rheinland, Intertek)
Client executes Agency agreements (required for new clients)
Submit final report to Agency for review and processing
For NRTL Mark, Agency sends client authorization to apply their safety mark
For CB Report, Agency sends client CB Report and Certificate
Trust in a Leader to Meet Your Deadlines
MECA is honoured to service 8 of the Top 10 Medical Manufacturers Worldwide as clients. (per MD&DI - December, 2015 Ranking)
Since 2002, MECA has been assembling the top medical equipment compliance specialists in the field, to help our clients
meet the required regulatory standards in a time-sensitive and cost-effective manner.
MECA’s Engineers are part of the IEC, ISO, & AAMI medical standards writing & interpretation process.
This gives you access to the expertise you need to meet the changing requirements and interpretations.
Switch to MECA and learn how the top medical device manufacturers get on the market faster.
Fully Accredited Lab, So Reports Are Accepted Internationally
MECA is an ISO 17025 accredited testing lab for medical and laboratory equipment.
Our ISO 17025 accreditations include A2LA with ilac MRA, the IECEE CB Scheme, UL, TUV Rheinland, and Intertek.
This means our reports are accepted by regulatory bodies world-wide.
US FDA, Health Canada, Brazil, European Union countries, Japan, China, Korea, etc. See full list of accepting countries.
Overview of Requirements
To place a medical device on the market in any country, you need to demonstrate that the device is safe and effective.
Using established international standards is the primary way to do this. The regulatory bodies in countries require review of
evidence that the device is safe to use before it can be placed on the market. Providing the compliance reports to the standards recognized by each country accomplishes this.
For medical equipment, it is the IEC 60601-1 standard, as well as the applicable Collaterals, Particulars, and national deviations
(US: AAMI ES 60601-1, Canada: CSA C22.2 No. 60601-1, and The European Union countries: EN 60601-1).
These are now harmonized to Edition 3.1.
Edition 3.1 of IEC 60601-1 (2012) is Edition 3 (2005) with Amendment 1 (2012), and is required by nearly all countries in the world.
The only country still requiring a report to Edition 2 is China.
For laboratory equipment, the standard is IEC 61010-1, as well as applicable Particulars and national deviations
(US: UL 61010-1, Canada: CSA C22.2 No. 61010-1, and The European Union countries: EN 61010-1).
See our new IEC 60601-1 HELP SITE at MECAssociates.us for additional help with the standards and requirements
PLEASE feel free to email or call me if you have general or specific questions about your device or compliance needs:
Brian Biersach firstname.lastname@example.org (262-347-3436)
Experts in the field of medical certification and regulatory compliance with a commitment to quality service