- Work With The Experts to Speed Your Device to Market -
For answers to your questions
Medical Equipment Compliance,
Certification, and Regulatory Services and Information
MECA Help Site
Medical Equipment Compliance Associates, LLC
Current IEC, ISO, and EN Standards List, With Publish Dates
This is the European OJ (Official Journal) site. Scroll just over half way down to the EN 60601-1 standards
Medical Device Directive (MDD)
(MDD 93/42/EEC for CE marking - pdf document download)
NOTE: Standards are copyrighted and not available in their published form for free
We suggest searching each source below for the best price on the standards you need
Component Certification Directories
The following are NRTL Certification directories for components and devices.
They are used to verify the compliance of components under the applicable standards by the specified NRTLs.
NOTE: Some now require setting up an account to access the directories.
UL Product IQTM Component Certification Directory - UL Recognized, Listed, Classified, Certified (now requires account and login)
Intertek - Certified Product Directory Search
TUV Rheinland - Certified Product Directory Search
CSA - Product Certification Directory Search
TUV SUD - Certificate Explorer Search
SGS - Certified Products Search
OSHA - Occupationa Safety and Health Administration list of Nationally Recognized Testing Laboratories (NRTL)
The following are associates that we have a long experience working with, and recommend for their high quality services
Test Equipment For Medical Devices
The following is test equipment that we use in our lab, and we have found to work exceptionally well.
whaleteq.com - Contact Brian Biersach (email@example.com) at MECA or firstname.lastname@example.org at WhaleTeq with questions.
Test and measurement equipment for medical equipment, primarily ECG and Electrosurgical Test and verification.
We use this test equipment in our lab for testing medical equipment for internationally accredited reports.
There is nothing we've found on the market that does what these ECG and Electrosurgical testers do.
Keystone Compliance is an A2LA accredited test lab specializing in EMC, vibration, temperature, ingress protection and
package testing. Keystone Compliance has a large scope of accreditation including significant experience working with
manufacturers to receive IEC 60601-1-2 certification. With five EMC chambers and a large environmental testing lab,
lead times for testing are short. Please visit www.keystonecompliance.com to learn more or to request a quote.
Minnetronix Inc. - Contact: Matt Cunningham
Medical equipment design, development, manufacturing services
Equipment conceptualization, design, commercialization, manufacturing, fulfilment, and sustaining services
Risk assessment and Risk Management solutions/.consulting for Life Science Companies.
Expertise includes IEC 60601-1, ISO 14971, ISO 13485, MDD 93/42/EEC, 21 CFR Part 820, AS/NZS ISO 31000, Annex 11,
21 CFR Part 11, and other regulations and standards.
Expertise also includes FDA submission support, quality assurance management system development, medical device technology
and software compliance, software validation, and business operations efficiency strategies for life science companies.
Medical device regulatory assistance, specializing in risk management based on ISO 14971,
usability based on IEC 62366, IEC 60601-1-6, and requirements for access to the European Union.
Regulatory Technology Services LLC - Contact: Mark Job (Buffalo, MN)
Accredited by the FDA to perform third-party reviews of FDA 510(k) submissions
More than 300 submissions averaging approximately 30 days from receipt of the submission
to receipt of the Substantial Equivalence letter from the FDA
Equipment conceptualization, design, commercialization, manufacturing, fulfillment, and sustaining services
FDA - Food and Drug Administration Home page
FDA - FDA recognized consensus standards search
IEC - International Electrotechnical Commission Home page
IEC Working Group TC 62 - Electrical equipment in medical practice
IEC Working Group 62A - General standard writing committees
IEC Working Group 62B - Imaging standards writing committees
IEC Working Group 62C - Nuclear/Radiation standards writing committees
*IEC Working Group 62D - Particular standards writing committees
IECEE - International Electrotechnical Commission for Electrical Equipment Home page
IECEE CB Scheme - List of IECEE CB Scheme Members
IECEE CB Scheme - MECA CB Scheme CBTL member information and scope
AAMI - Association for the Advancement of Medical Instrumentation (Home page)
AAMI - Standards