CASE STUDY:

JiT (Just in Time) Certification for ISO 13485

ECM (Ente Certificazione Macchine) is a Notified Body (#1282) and an accredited ISO 13485 Certification Body supporting European market access for medical devices and other products. Through offices, laboratories and an extensive partner network in Asia, North America, Europe, Middle East, ECM delivers reliable, efficient and responsive services.

ECM is headquartered is in Italy with presences in the USA, Canada, Korea, Japan, China Mainland, India and Iran. Our laboratory in Italy together with our associated labs, are accepted for testing within many international schemes. Certification of products to the European Directives is offered through our head office in Italy.

Our team of professionals (of which over 65% are engineers) is dedicated to helping manufacturers bring safe and quality medical devices to global markets through our efficient testing and certification programs.

Our commitment to customer service and operational efficiency shortens time to market for medical devices and improves patient lives. What sets ECM apart is:

  • Efficiency – Solutions tailored to your needs
  • Time to Market Matters – Approvals in weeks rather than months
  • Experience Matters - Notified Body expert for testing, inspection, and certification

Accredited tests are recorded on the website www.accredia.it

ECM is an official Notified Body for products falling under the European directives for:

  • 93/42/EEC -Medical Devices Directive
  • 2014/68/EU - Pressure Equipment Directive
  • 2014/34/UE - ATEX certification
  • 2014/30/EU – EMC (Electromagnetic compatibility) Directive
  • 2006/42/EC - Machinery Directive
  • 2014/35/EU - Low Voltage Directive
  • 2014/33/UE – Lift Directive
  • Authorized for German GS-mark certification

ECM maintains various national accreditations:

  • Product certification according to ISO/IEC 17065
  • Management system certification to ISO/IEC 17021
  • Testing services according to ISO/IEC 17025
  • Training

The associated laboratories have accreditations by Russian GOSSTANDART, Chinese CNAS, Korean RRL, Australian NATA, German ZLS, Canadian SCC and US OSHA.

Ente Certificazione Macchine
Via Cà Bella, 243
40053 Valsamoggia
Location Castello di Serravalle (Bo) Italy

P. +39 051 6705141
F. +39 051 6705156