Kimball Electronics to help support our customers with new regulatory compliance provisions of the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Nov 04, 2019
At Kimball Electronics we foster innovation, uniquely positioning us to provide the experience, knowledge, and capabilities to effectively support cutting-edge Medical customers.
ISO13485 Certified
FDA Registered – FDA CFR Parts 820, 210, 211, 4, 11 and 901
MedAccred Accreditation
Utilizing common production and support capabilities for medical manufacturing globally, our contract Electronics Manufacturing Services (EMS) and Diversified Contract Manufacturing Services (DCMS) teams provide manufacturing, engineering and supply chain services, design and testing services, as well as regulatory support process management.
EU MDR and IVDR Support
The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 25th, 2017. The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant. Our strong track record with ISO13485 and FDA, as well as Medical Device manufacturing expertise, allows Kimball Electronics to support our customers with new regulatory compliance provisions of the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
What is are the practical implications for manufacturers?
Conformance with the EU MDR and IVDR is a significant business challenge that must be overcome in order to enjoy continued access to the EU market. To meet this challenge medical device manufacturers must be proactive and begin preparing now and Kimball Electronics can help.
How can Kimball Electronics help?
Our strong track record with ISO13485 and FDA, as well as Medical Device manufacturing expertise, allows Kimball Electronics to support our customers with new regulatory compliance provisions of the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Our agility and responsiveness ensure quick time-to-market, enabling Kimball Electronics to keep pace with the ever-evolving medical market. We provide expertise in cold chain management, drug delivery device production, sterilization, disposable device production, scientific injection molding, and complete full-system assembly.
From one of our 8 global manufacturing facilities in Poland, we can support our customers with products for the entire continuum of care:
Early Diagnostics: Imaging, Disposable Test Strips
Hospital Care: Surgical, Monitoring, AEDs, Ventilation
Therapy: Drug Delivery and Efficiency
Home Healthcare: Drug Delivery, Respiratory Care, Remote Monitoring
We’re proud that our customers, the pacesetters of the Medical industry, choose to partner with Kimball Electronics.
Members of our Medical Business Development Team will be in attendance at Medica in Dusseldorf, Germany - November 18-21. We welcome the opportunity to meet with you to discuss our Kimball Electronics Medical capabilities!
Contact +1 262 366 5815 or +48 600241894 to schedule a time to meet.
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