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Medical device product development and manufacturing requires an in-depth knowledge of the regulatory standards regarding validation and traceability. IEC Electronics has extensive experience with the complex electronic assemblies required for Class II and Class III medical devices.
Utilizing our on-site laboratories combined with proven industry expertise, IEC Electronics solves challenges and optimizes the process capability to qualify, validate, and manufacture our customer’s products.
The Product Acceleration Center at IEC Electronics focuses on risk assessment and mitigation while supporting critical path timelines to accelerate your product to market.
IEC Electronics has the engineering know-how to develop robust test strategies in addition to designing and building custom functional testing systems that simulate the end product functionality for your life-saving products.
Utilizing our on-site laboratories combined with industry know-how –our capabilities include component level traceability to ensure your product can be effectively validated.
IEC Electronics can manufacture your complex electronics, custom cables, and metal enclosures to build it into a full system medical device assembly.
IEC Electronics is ISO 13485 certified and a FDA registered site.
| Electronics Expertise for Medical Applications |
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Resuscitation systems Surgical navigation systems Infusion delivery systems Injection systems for diagnostic imaging Medical imaging devices Remote/wireless diagnostics |
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Certifications & Services |
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ISO 13485 certified FDA registered IPC & J-STD certified Clean room manufacturing Verification & Validation – class II & III Conformal coating including acrylic, silicone and polyurethane Advanced Analysis & Testing Laboratories End order fulfillment & logistics management |