MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.
CLEAN ROOM & ASSEMBLY
Clean Room Overview
Our clean rooms are designed to meet stringent standards essential for medical device manufacturing. With options ranging from ISO-5 to ISO-8 classifications, we control particle levels, humidity, and temperature to support various processes from aseptic manufacturing to final assembly and packaging. Each clean room is equipped with HEPA filters, pass-through chambers, and interlock doors to maintain integrity.
Full Assembly Capabilities
We offer end-to-end medical device assembly, from component integration to sterilization. Each device undergoes quality checks at every stage, ensuring full regulatory compliance, reliability, and safety. Our full assembly services streamline production, delivering devices ready for market distribution.
The full assembly process can include
Benefits of In-House Clean Rooms & Device Assembly
With in-house clean rooms and final assembly, our process minimizes handling, contamination risk, and lead times—providing a cost-effective solution for high-quality medical device manufacturing.
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What classifications of clean rooms does Vitatek offer for medical device assembly?VitaTek offers ISO Class 5 and Class 7 clean rooms for medical device assembly, compliant with ISO 13485, FDA CFR 21 Part 820, ISO 14971, and ISO 14698 standards. These clean rooms meet rigorous biocontamination control and risk management requirements, ensuring top-quality medical device manufacturing.
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How does a clean room environment help maintain product quality and compliance?A clean room maintains product quality and compliance by strictly controlling particulates, temperature, and humidity, which minimizes contamination risks. This controlled environment is essential for meeting regulatory standards, ensuring medical devices are safe, sterile, and reliable for patient use.
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What processes are completed in a medical clean room versus a standard assembly area?A medical clean room handles processes like sterilization, final assembly, packaging, and inspection under strict contamination controls, ensuring device safety and regulatory compliance. Standard assembly areas, with less stringent controls, are used for non-sterile tasks like general assembly or initial testing that don't require low-particulate environments.
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What are the typical quality control measures taken in clean room assembly?Typical quality control measures in clean room assembly include monitoring air quality, regular equipment sterilization, precise environmental controls (temperature, humidity), and frequent particulate testing. Devices undergo inspections at each stage to ensure cleanliness, functionality, and adherence to regulatory standards, safeguarding device safety and reliability.
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How does Vitatek ensure that clean room and assembly standards meet regulatory requirements?VitaTek ensures that clean room and assembly standards meet regulatory requirements by following strict ISO 13485 and FDA GMP guidelines. We perform routine audits, monitor environmental conditions, and validate equipment regularly. Additionally, our team is thoroughly trained, and we maintain comprehensive documentation to ensure ongoing compliance and device safety.
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Can Vitatek handle sterilization and final assembly in-house, and what advantages does this provide?Yes, VitaTek handles both sterilization (ETO) and final assembly in-house. Our vertically integrated services streamline communication and timelines, ensuring faster development and quicker time to market. This approach simplifies the process for customers, reduces lead times, and accelerates medical device commercialization.