How We Help
MECA assists medical device companies with safety certification and ISO 17025 accredited compliance reports to meet your 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 testing and certification support that you will find anywhere.
MECA tests and documents compliance to the required medical and laboratory equipment standards.
Medical equipment standards: IEC 60601-1 with national differences, etc. : US (AAMI ES), Europe (EN), Canada (CSA)
Laboratory equipment standards: IEC 61010-1 with national differences, etc. : US (UL), Europe (EN), Canada (CSA)
MECA is honored to service 8 of the Top 10 Medical Manufacturers Worldwide as clients. (per MD&DI – December, 2018 Ranking)
Since 2002, MECA has been assembling the top medical equipment compliance experts in the field, to help our clients meet the required safety standards in a time-sensitive and cost-effective manner.
Our engineers are engaged directly in the IEC, ISO, AAMI, and IECEE global standards development & application process. This gives you access to the expertise you need to meet the changing requirements and interpretations.
OUR REPORTS ARE ACCREDITED TO FACILITATE INTERNATIONAL ACCEPTANCE
MECA is accredited to ISO 17025 as a testing laboratory for medical and laboratory equipment. Our accreditations include A2LA with ilac MRA, IECEE CB Scheme, UL, TUV Rheinland, and Intertek.
With these accreditations, MECA issued reports can be accepted by regulatory bodies world-wide:
US FDA, Health Canada, Brazil, European Union countries, Japan, China, Korea, etc.