CLEAN ROOM & ASSEMBLY

MEDICAL DEVICE CLEAN ROOM AND FULL DEVICE ASSEMBLY

ISO 13485 Compliant
7,000 SQ FT Clean Room
Certified ISO 5 & 7 Clean Rooms

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.

FDA CFR 21 Part 820

Quality System Regulation – Medical Devices

ISO 13485 Medical Devices

Quality management systems — Requirements for regulatory purposes

ISO
14971

Medical devices — Application of risk management to medical devices

ISO
14698

Cleanrooms and associated controlled environments — Biocontamination control

ISO
14644-1

Cleanrooms and associated controlled environments

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

Component Integration

Putting together all individual components, from electronic parts to mechanical pieces, into a complete device.

Quality Control and Testing

Rigorous testing at each assembly stage to ensure that the device meets required quality, safety, and performance standards.

Sterilization and Packaging

Often, full assembly includes sterilization and packaging the device in a controlled, clean environment to maintain sterility and prevent contamination.

Regulatory Compliance

Ensuring that each assembly process adheres to regulatory standards like ISO 13485 or FDA guidelines for medical devices.

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.

MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.

CLEAN ROOM & ASSEMBLY

MEDICAL DEVICE CLEAN ROOM AND FULL DEVICE ASSEMBLY

Clean Room Overview

FDA CFR 21 Part 820

ISO 13485 Medical Devices

ISO
14971

ISO
14698

ISO
14644-1

Full Assembly Capabilities

The full assembly process can include

Component Integration

Putting together all individual components, from electronic parts to mechanical pieces, into a complete device.

Quality Control and Testing

Rigorous testing at each assembly stage to ensure that the device meets required quality, safety, and performance standards.

Sterilization and Packaging

Often, full assembly includes sterilization and packaging the device in a controlled, clean environment to maintain sterility and prevent contamination.

Regulatory Compliance

Ensuring that each assembly process adheres to regulatory standards like ISO 13485 or FDA guidelines for medical devices.

Benefits of In-House Clean Rooms & Device Assembly

Minimizes
Handling

Minimizes Contamination Risk

Minimizes Lead Times

MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.

CLEAN ROOM & ASSEMBLY

MEDICAL DEVICE CLEAN ROOM AND FULL DEVICE ASSEMBLY

Clean Room Overview

FDA CFR 21 Part 820

ISO 13485 Medical Devices

ISO 14971

ISO 14698

ISO 14644-1

Full Assembly Capabilities

The full assembly process can include

Component Integration

Putting together all individual components, from electronic parts to mechanical pieces, into a complete device.

Quality Control and Testing

Rigorous testing at each assembly stage to ensure that the device meets required quality, safety, and performance standards.

Sterilization and Packaging

Often, full assembly includes sterilization and packaging the device in a controlled, clean environment to maintain sterility and prevent contamination.

Regulatory Compliance

Ensuring that each assembly process adheres to regulatory standards like ISO 13485 or FDA guidelines for medical devices.

Benefits of In-House Clean Rooms & Device Assembly

Minimizes Handling

Minimizes Contamination Risk

Minimizes Lead Times

ISO
14971

ISO
14698

ISO
14644-1

Minimizes
Handling