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Mr. Hu Bo
Regulatory Manager
Address:
Unit 1201, Unit 2, 11th Floor, Building 1, No. 3 Changtong Road, Chaoyang District, Beijing 01, Beijing, China
Telephone:
Zip Code:
Fax:
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Account Registered in:
2024
Business Range:
Service
Management System Certification:
ISO 9001
Business Type:
Manufacturer/Factory, Other
Company Introduction
Production Capacity
Ellecom - Regulatory and Compliance Solutions for Medical Devices and In Vitro Diagnostics
Ellecom has expertise and competence in meeting demanding regulatory requirements in an international context. We are a leading partner in the execution and tracking of regulatory, clinical and technical documentation. This enables us to provide maximum efficiency in product registration.
The changing ...
Ellecom has expertise and competence in meeting demanding regulatory requirements in an international context. We are a leading partner in the execution and tracking of regulatory, clinical and technical documentation. This enables us to provide maximum efficiency in product registration.
The changing ...
Ellecom - Regulatory and Compliance Solutions for Medical Devices and In Vitro Diagnostics
Ellecom has expertise and competence in meeting demanding regulatory requirements in an international context. We are a leading partner in the execution and tracking of regulatory, clinical and technical documentation. This enables us to provide maximum efficiency in product registration.
The changing regulatory framework created by the implementation of the EU Medical Devices Regulation (2017/745) and the EU In Vitro Medical Devices Regulation (2017/746) is impacting how medical devices and IVDs are reclassified and, where applicable, upscaled.
Companies with knowledge and experience of regulatory issues will find it easier to ensure a smooth transition.
Over the years, Ellecom has established sustainable business relationships with various competent authorities, notified bodies, clinical laboratories and think tanks.
Ellecom has expertise and competence in meeting demanding regulatory requirements in an international context. We are a leading partner in the execution and tracking of regulatory, clinical and technical documentation. This enables us to provide maximum efficiency in product registration.
The changing regulatory framework created by the implementation of the EU Medical Devices Regulation (2017/745) and the EU In Vitro Medical Devices Regulation (2017/746) is impacting how medical devices and IVDs are reclassified and, where applicable, upscaled.
Companies with knowledge and experience of regulatory issues will find it easier to ensure a smooth transition.
Over the years, Ellecom has established sustainable business relationships with various competent authorities, notified bodies, clinical laboratories and think tanks.
Factory Address:
Unit 1201, Unit 2, 11th Floor, Building 1, No. 3 Changtong Road, Chaoyang District, Beijing 01, Beijing, China