MECA - Guidance & services for testing and documenting compliance to the required medical and laboratory equipment standards: IEC 60601-1, AAMI ES 60601-1, CSA C22.2 No. 60601-1, EN 60601-1
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Medical Equipment Compliance Associates, LLC
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Medical Equipment Compliance Associates, LLC
Brian Biersach
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View this contact
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MECA Home: IEC 60601-1 Standards Compliance and Certification (IEC, UL, AAMI, CSA, EN) | 60601-1.com Reviews
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MECA - Guidance & services for testing and documenting compliance to the required medical and laboratory equipment standards: IEC 60601-1, AAMI ES 60601-1, CSA C22.2 No. 60601-1, EN 60601-1
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To Speed Your Device to Market -. For answers to your questions. Speak with Brian Biersach at:. This Page Has Moved. Thank you for visiting our website. See the above links for for our new website layout. Experts in the field of medical certification and regulatory compliance with a commitment to quality service. 2016 Medical Equipment Compliance Associates, LLC. Certification Marks provided are registered trademarks of the applicable agencies. Photos/illustrations credit: canstockphoto.com.
IEC 60601-1 Medical Device Safety Testing, Reports (MECA Services)
http://www.60601-1.com/services.html
To Speed Your Device to Market -. For answers to your questions. Speak with Brian Biersach at:. IEC 60601-1 Guidance, Medical Device Safety Testing. MECA has become a trusted partner with many of the world's medical device and laboratory equipment leaders, and has been. Able to meet their demanding time and budgetary requirements. Whatever your compliance needs are, when you work with the. Edical equipment evaluation, safety testing, and report, for demonstrating compliance to standards. The TRF includes...
ISO 17025 Accredited Testing Reports, Certificates
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To Speed Your Device to Market -. For answers to your questions. Speak with Brian Biersach at:. ISO 17025 Certificates for Accredited Testing Reports,. MECA was formed in 2002, to assist medical device companies with safety certification, ISO 17025 accredited compliance reports, and regulatory needs. We have grown our business and our network of associates with the leaders in their respective fields, to offer the highest level of certification and regulatory support that you will find anywhere. MECA has ...
MECA Quote Submission
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To Speed Your Device to Market -. For answers to your questions. Speak with Brian Biersach at:. To receive a complete quote, please complete the quote submission form:. Link to Quote Submission Page. You will receive a confirmation email if the form was submitted successfully. For information on the services we provide, please see the. To ask questions about a submission, or to send additional information,. Please feel free to contact us at info@60601-1.com. We provide the first 15 minutes free. If you h...
Medical Device FDA Requirements and IEC60601-1 Information
http://www.60601-1.com/information.html
To Speed Your Device to Market -. For answers to your questions. Speak with Brian Biersach at:. Medical Device FDA Requirements, IEC 60601-1 Standards. Help With Your Compliance Questions, FAQ. If you're on this page, you're likely trying to find specific information to answer a compliance question, or just trying to understand. The regulatory and standards requirements (FDA, CE Marking, etc.) to place your device on the US and international markets. Additional information is now provided on the new.
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Help With The IEC 60601 Standards And Regulatory Requirements
http://www.mecassociates.us/index.html
To Speed Your Device to Market -. Medical Equipment Compliance Associates, LLC. For answers to your questions. Speak with Brian Biersach at:. IEC 60601-1 Standards Information. Also see our main site at. What are the standards used for and why do I need to meet them? Medical devices/equipment is held to a higher level of safety than almost all other types of equipment on the market. Medical Standards List with Publish Dates). All of these applicable standards are used to show your device is safe and meet...
Medical Equipment Compliance: MECA Compliance Info. now on Twitter and LinkedIn
http://60601-1.blogspot.com/2014/09/meca-compliance-info-now-on-twitter-and.html
Designing and Evaluating Medical Equipment to International Safety and Essential Performance Standards (Requirements, Testing, Documentation, Standards Development). Tuesday, September 30, 2014. MECA Compliance Info. now on Twitter and LinkedIn. All of our updates are now being posted on:. MECA Website: 60601-1.com. LinkedIn: MECA - Medical Equipment Compliance Associates, LLC. Posted by Brian Biersach @ 2:09 PM. Oak Creek, WI, United States. View my complete profile.
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Medical Equipment Compliance
Designing and Evaluating Medical Equipment to International Safety and Essential Performance Standards (Requirements, Testing, Documentation, Standards Development). Tuesday, September 30, 2014. MECA Compliance Info. now on Twitter and LinkedIn. All of our updates are now being posted on:. MECA Website: 60601-1.com. LinkedIn: MECA - Medical Equipment Compliance Associates, LLC. Posted by Brian Biersach @ 2:09 PM. Oak Creek, WI, United States. View my complete profile.
MECA Home: IEC 60601-1 Standards Compliance and Certification (IEC, UL, AAMI, CSA, EN)
For answers to your questions. Speak with Brian Biersach. To Speed Your Device to Market -. Guidance and services for testing and documenting compliance to the required medical and laboratory equipment standards. Medical equipment standards: IEC 60601-1, national deviations (ES 60601-1, EN 60601-1, CSA C22.2 No. 60601-1, UL 60601-1). Laboratory equipment standards: IEC 61010-1, national deviations (EN 61010-1, CSA C22.2 No. 61010-1, UL 61010-1). Label, IFU Checklist. Call or Email Us. The standard is IEC...
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