Ellecom
Ellecom GmbH specializes in regulatory solutions, market access, and electronic components. They support clients with compliance, certification, and procurement services in the medical device and IVD sectors, as well as electronic parts. The company is active internationally, participating in trade fairs and providing expert consulting on standards like MDR, IVDR, GMP, ISO certifications, and QMS partnerships. Ellecom also offers a range of products, services, and consultancy to facilitate market entry and regulatory compliance for medical and electronic products. Ellecom is also ISO 9001:2015 and ISO 27001:2017 certified, emphasizing quality management and information security.
Industries
Nr. of Employees
small (1-50)
Products
Medical device product assortment (catalog)
A product assortment of medical devices and consumables sourced from various manufacturers, available for commercial distribution.
Company product list PDF and corporate profile
Downloadable product list and corporate profile documents describing offered product categories and company services.
Medical device product assortment (catalog)
A product assortment of medical devices and consumables sourced from various manufacturers, available for commercial distribution.
Company product list PDF and corporate profile
Downloadable product list and corporate profile documents describing offered product categories and company services.
Services
Consulting covering regulatory strategy, gap analyses, technical documentation review, CE‑marking preparation and EUDAMED registration support.
Provision of authorized representative functions and support for device registration and market entry in the EU, Switzerland and select international markets.
Design and implementation of quality and information security management systems, support for ISO 9001 and ISO 27001 certification preparation, audits and continuous improvement activities.
Partnership-based QMS support for regional manufacturers, including training on ISO 13485 requirements and assistance preparing technical documentation for CE marking.
Advisory services to introduce and implement GMP guidelines, including site assessments and process implementation support.
Global sourcing and procurement of end-of-life electronic components using an international supplier network and inventory search.
Consulting covering regulatory strategy, gap analyses, technical documentation review, CE‑marking preparation and EUDAMED registration support.
Provision of authorized representative functions and support for device registration and market entry in the EU, Switzerland and select international markets.
Design and implementation of quality and information security management systems, support for ISO 9001 and ISO 27001 certification preparation, audits and continuous improvement activities.
Partnership-based QMS support for regional manufacturers, including training on ISO 13485 requirements and assistance preparing technical documentation for CE marking.
Advisory services to introduce and implement GMP guidelines, including site assessments and process implementation support.
Global sourcing and procurement of end-of-life electronic components using an international supplier network and inventory search.
Expertise Areas
- MDR and IVDR regulatory compliance
- CE marking and EUDAMED registration
- IVD performance evaluation and analytical study coordination
- Quality management systems (ISO 9001, ISO 13485) implementation
Key Technologies
- IVD performance evaluation studies
- EUDAMED registration and conformity assessment processes
- ISO 9001 QMS implementation
- ISO 13485 QMS implementation
News & Updates
Ellecom at Medtec China 2024 in Shanghai
Ellecom participated in Medtec China, showcasing their services to an international audience from September 25-27, 2024.
Ellecom at FIME 2024 in Miami Beach
Ellecom attended FIME in Miami Beach from June 19-21, 2024, engaging with North and South American markets.
Ellecom's ISO 27001:2017 Certification
Ellecom's information security management system is certified by DEKRA, adhering to ISO 27001:2017 standards.
Ellecom's Participation in Arab Health 2024 Dubai
Ellecom participated in Arab Health 2024 in Dubai from January 29 to February 1, 2024, engaging with Middle Eastern healthcare providers.
Ellecom at Medica 2023 in Düsseldorf
Ellecom showcased their services at Medica 2023, one of the world's largest medical trade fairs, in November 2023.
Ellecom's QMS Partnership with Hebei Province, China
Ellecom became a QMS partner for Hebei Province, supporting local industry standards and certification processes.
Ellecom at Medtec China 2024 in Shanghai
Ellecom participated in Medtec China, showcasing their services to an international audience from September 25-27, 2024.
Ellecom at FIME 2024 in Miami Beach
Ellecom attended FIME in Miami Beach from June 19-21, 2024, engaging with North and South American markets.
Ellecom's ISO 27001:2017 Certification
Ellecom's information security management system is certified by DEKRA, adhering to ISO 27001:2017 standards.
Ellecom's Participation in Arab Health 2024 Dubai
Ellecom participated in Arab Health 2024 in Dubai from January 29 to February 1, 2024, engaging with Middle Eastern healthcare providers.
Ellecom at Medica 2023 in Düsseldorf
Ellecom showcased their services at Medica 2023, one of the world's largest medical trade fairs, in November 2023.
Ellecom's QMS Partnership with Hebei Province, China
Ellecom became a QMS partner for Hebei Province, supporting local industry standards and certification processes.