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Manufacturing services
Prototyping Medical Devices
ISO 13485 For Startups

Manufacturing and Quality Inspection

Plastic and Metal injection moulding

6 tons machine, 125 cubic cm shot for intricate plastic and metal parts. Less startup cost for mould. Fully auto cycles available.

Dual asymmetric centrifugal mixer

Suitable for mixing MIM feedstock, cosmetics, paints, polymers, and pharmaceutical mixtures. Up to 2,500 RPM of mixing is supported.

Visual measuring
(for QA and QC)

Precision visual inspection for up to 1 µm of tolerance. X, Y, and Z measurements suitable for machined and moulded parts.

Laser marking and blister packaging

Complete packaging solution from metal laser marking to blister packaging sealing process. Consultation on sterilization services.

Laminar flow and ultrasonic cleaning

Vertical laminar flow cabinet for cleanroom requirement. We also offer ultrasonic cleaning services for machined and moulded parts

FDM 3D printing (rapid prototype)

Present your idea and innovation to your stakeholders using 3D printed model. We offer fast and affordable custom model.

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Equipment Rental Services

RM 45 per hour

RM 650 per day

RM 55 per day

RM 75 per hour

RM 450 per day

RM 150 per day

RM 25 per sample

RM 5 per hour

RM 150 per day

Prototyping the
medical devices

Step 1

Communicate with us regarding your idea and innovation

Step 2

Discussion on "intended use" as per ISO 14971 Risk Management

Step 3

Finalizing the regulatory requirements + risk assessment

Step 4

Identifying resources, developing supplier evaluation procedure, bill of materials etc.

Step 5

Developing the prototype, establishing the production manual and quality plans

Step 6

Review of the prototype, suggestion of the possible improvements

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ISO 13485 for Start-ups

Training and awareness

  • In depth awareness
    Review on ISO 13485 requirements clause by clause. Suitable for start-up founder and medical device innovator.
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  • Students training
    Hands-on experience for implementing ISO 13485 quality management system. Suitable for engineering students.
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  • Staff training
    Training for employees. Reviewing the requirements, implementing CA/PA for continuous improvement.

QMS development

  • Quality manual
    Development of procedures and forms. Including the development of masterfiles in accordance with ISO 13485.
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  • Procedures and forms
    Development of procedures and forms. Including the development of masterfiles in accordance with ISO 13485.
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  • Production and quality plans
    Production manual, including the process validation and verification. Quality plans and specifications.
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Internal audit

  • Program development
    We help you develop the internal audit procedure and templates such as audit memo, plan and report
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  • Audit services
    We have competent personnel to conduct an audit for you. The service includes a management review.
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