Medical device manufacturing requires controlled environments that support sterility, precision assembly, biocompatibility, and strict regulatory compliance. Whether you produce implantables, diagnostics, surgical instruments, single-use disposables, or electronic medical equipment, MRC Cleanroom Systems delivers reliable, hygienic, and fully compliant cleanroom solutions tailored to medical device production.

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Our Services for the Medical Device Industry

MRC provides a fully integrated cleanroom solution, including:

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• Cleanroom design & consultancy

• Turnkey construction

• HVAC & MEP engineering

• MRC GRP and MRC HPL modular cleanroom panels

• Doors, vision panels, pass-boxes and accessories

• Validation support (IQ/OQ/PQ)

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Our GRP and HPL panels offer exceptional hygiene, non-shedding surfaces, chemical resistance, and long-term durability — ideal for sterile processing, assembly, and packaging in medical device environments.

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Regulatory & Specification Considerations

We design and build medical device cleanrooms fully aligned with:

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• ISO 13485 – Medical device quality management

• ISO 14644-1 / ISO 14644-2 – Cleanroom classification & monitoring

• EU MDR / FDA 21 CFR Part 820 – Quality system regulations

• Biocompatible, non-shedding, and cleanable material requirements

• Temperature, humidity, and pressure cascade control for assembly and sterilisation workflows

• Environmental monitoring & contamination control strategies

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We incorporate process-driven design principles for device assembly, sterile barrier packaging, powder handling, moulding, extrusion, and electronics manufacturing — ensuring smooth material flow and validated environmental conditions.

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Why Choose MRC for Medical Device Facilities?

• Extensive global experience delivering ISO-compliant cleanrooms

• GRP panels that provide superior hygiene compared to steel or coated systems

• Walk-on ceilings and high-strength construction for equipment access

• Proven solutions for sterile, non-sterile, and high-precision manufacturing areas

• Low lifecycle cost and reliable long-term performance

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Build Your Next Medical Device Cleanroom

Speak to our team for early design support, retrofits, controlled environment expansions, or complete turnkey medical device manufacturing facilities.