3D INSTRUMENTATION is specialized in Trauma, Knee, Hip & Spine Instruments. Call us about your manufacturing needs today!
We specialized in manufacturing services to produce Orthopedic Implants. Our areas of expertise include: Nail Implants, Plate Implants & Screw Implants.
At 3D Instrumentation Sdn Bhd, we understand the importance of quality management systems (QMS) within the medical device industry. That's why we're proud to have earned ISO 13485:2016 certification, an internationally agreed standard that specifies the requirements for a QMS within companies that provide medical devices and related services.
Since 2015, our QMS has been designed to establish and maintain the effectiveness of our processes, ensuring the consistent design, development, production, assembly, and delivery of medical devices that are safe for their intended purpose. We've earned certification from accredited bodies, such as the prestigious Royal Chartership BSI Group, known for its expertise in certification and assessment.
Our ISO 13485:2016 certification demonstrates our long-standing commitment to quality and safety in every aspect of our business. You can trust us to deliver innovative and reliable solutions that meet the highest standards in the medical device industry.
We service the worldwide orthopedic industry with specialized contract manufacturing services to produce surgical instruments, nail implants, plate implants and screw implants of the highest quality from Penang, Malaysia.
3D INSTRUMENTATION is located in Juru Prime industrial Park, Penang, Malaysia.
We feel fortunate to be operating in an industry that holds the power to affect lives in such a profound way and we are proud of the services we offer.
To be Malaysia's market leader in orthopedic medical devices by implementing complete One - Stop Contract Manufacturing Solution.
Maximizing customer Quality and On-time Delivery satisfaction are 3D INSTRUMENTATION’s primary objectives.
3D Instrumentation Sdn Bhd has been established since 2013.
3D INSTRUMENTATION accredited ISO 13485 & ISO 9001 certification.
3D INSTRUMENTATION approved by Taiwan FDA.
3D INSTRUMENTATION has been rated 3 Star under SME COMPETITIVENESS RATING FOR ENHANCEMENT (SCORE).
Setup new Heated Nitric & Heated Citric Passivation line.
FDA (U.S. Food and Drug Administration) registered Medical Devices.
3D INSTRUMENTATION approved by PMDA (Japan FDA).
Setup new Ultrasonic Cleaning Process.
Installation Qualification of the Electro Polishing Process line which includes Heated Detergent Pre-Clean, Spray Rinsing Tank, Electro Polishing Tank and Immersion Rinsing Tank.
Installation of new 3D Technology Laser Engraving Machine.
Installation of new CNC Autolathe CITIZEN L12-1MQ Machine to support needle and <=12mm small diameter parts.
Installation of new CHEVALIER FCL-200HT Turning Machine.
Installation of new CNC Autolathe Star SB-20R TYPE G Machine.