Incap Estonia received the latest version of ISO 13485:2016 Quality Management System for electronics manufacture of medical devices
Release 23 July 2018
INCAP ESTONIA RECEIVED THE LATEST VERSION OF ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR ELECTRONICS MANUFACTURE OF MEDICAL DEVICES
Incap's factory in Kuressaare passed successfully another audit and is now the only electronics manufacturing services provider in Estonia having the latest (2016) version of the certificate for manufacturing electronics for medical devices and related services.
Incap's interim CEO and managing director of Incap's subsidiary in Estonia, Otto Pukk, explained that the factory has manufactured components for different projects in medical field also before and is ready to take up new projects. "The result of the audit confirmed that all our documents and processes are in line with requirements for producing electronic components for medical sector - for example electronic components for different devices in hospitals, which help conduct researches and provide diagnoses or conduct operations," Pukk explains.
"We have had several projects in this field before, too - for example, we have manufactured control panels and power supplies for mammography equipment and manufactured parts for heart beat monitors. With the latest version of our quality management system, we are now ready to take up new exciting projects from medical field," says Pukk.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities, such as technical support.
Otto Pukk, interim CEO and managing director of Incap's subsidiary in Estonia, tel.+372 508 0798
INCAP IN BRIEF
Incap Corporation is an international contract manufacturer. Incap's customers are leading suppliers of high-technology equipment in their own business segments, and Incap increases their competitiveness as a strategic partner. Incap has operations in Finland, Estonia, India and China, and the company currently employs approximately 570 people. Incap's share is listed on the Nasdaq Helsinki Ltd. as from 1997. Additional information: www.incapcorp.com.