Ente Certificazione Macchine Srl.

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Ente Certificazione Macchine Srl (ECM) was founded in 1996 with headquarters near Bologna, Italy. We are present worldwide with offices in the US, China, Korea, Japan, Iran, India, Israel and Turkey.

We are a EU Notified Body for several EU Directives and are providing the following solutions to the medical device industry in North America:

- CE Marking - Notified Body (#1282) for the Medical Device Directive (93/42/EC)
- Certification Body for ISO 13485 and ISO 9001
- Accredited Testing Laboratory (ISO 17025)
- NCB and CBTL for IECEE CB Scheme
- International Approvals including China CFDA and Japanese PMDA
- Training

ECM Benefits:
- FAST - Shortest lead time for audits and reviews
- TRANSPARENT Process: Online project tracking, document sharing and direct communication
- LOCAL: Local auditors and coordinators
- ECONOMICAL: faster certification, competitive pricing

Company Details

Address
Unit 506 - 1110 Brickell Avenue
Miami, FL 33131

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