Supercomal Medical Products Sdn. Bhd.

FDA Establishment registration and device listing

Establishment registration and device listing

Supercomal Medical Products Sdn. Bhd.

Empowering future by our

top notch services

Empowering future by our

top notch services

 World Class Services

At Supercomal Medical Products Sdn Bhd, we provide a wide range of top-notch services for our client. From PCB assembly and programming to plastic injection services, we work our best to deliver the exceeding expectation of our customers and business partners with our safe and effective services.

Research and Development

 

Research and development are activities that Supercomal Medical Products Sdn. Bhd. undertake to innovate and introduce new products and services.

We intended to create a new or improved technology that can provide competitive advantages at the business, industry or national level.

Tooling Fabrication

 

Equipment designed to facilitate the production of goods.

Creating dies and moulds, machines, fixture and CNC machining.

The process begins with prototype, and upon iterating, the finished prototype serves as a model for fabrication.

Process Validation: Installation Qualification, Operational Qualification and Performance Qualification

 

Performed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) which to defined as the data collection and evaluation of data, from the process design stage throughout production, which establishes evidence that a process is capable of consistently delivering quality products.

In House Testing

 

Accelerated Aging Test
Testing that uses accelerated conditions
of humidity and heat to speed up the normal aging processes of items.

Bending Test
Bending mechanical test are performed to evaluate the bending strength or fatigue resistance of the device to bending.

Tensile Strength Test
Ultimate way to test the maximum force of
a product can withstand until reach its weaken point.

Sterilization
A compulsory stages after external sterilization process completed. Sterilization Validation Activities will be implemented to make sure the sterilized products are qualified before hand off to customers.

Printing

 

To provide the best detailed printed on
our products and also fast forward to the latest technology.

- Laser Printing
- Pad Printing
- Injection Printing

Transportation and Bubble Test Validation

 

Transportation Test
Follow ASTM D41659 Standard , Packaging Testing provide assurances that packaging will protect our products from damage or degradation during the transportation and distribution process.

Bubble Leak Test
Follow ASTM F2096 Standard Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization Bubble leak testing is a whole-package integrity test. It is typically performed as part of a validation activity, such as sealer validation, or transit or shelf life simulations.

 World Class Services

At Supercomal Medical Products Sdn Bhd, we provide a wide range of top-notch services for our client. From PCB assembly and programming to plastic injection services, we work our best to deliver the exceeding expectation of our customers and business partners with our safe and effective services.

Research and Development

 

Research and development are activities that Supercomal Medical Products Sdn. Bhd. undertake to innovate and introduce new products and services.

We intended to create a new or improved technology that can provide competitive advantages at the business, industry or national level.

Tooling Fabrication

 

Equipment designed to facilitate the production of goods.

Creating dies and moulds, machines, fixture and CNC machining.

The process begins with prototype, and upon iterating, the finished prototype serves as a model for fabrication.

Process Validation: Installation Qualification, Operational Qualification and Performance Qualification

 

Performed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) which to defined as the data collection and evaluation of data, from the process design stage throughout production, which establishes evidence that a process is capable of consistently delivering quality products.

In House Testing

 

Accelerated Aging Test
Testing that uses accelerated conditions
of humidity and heat to speed up the normal aging processes of items.

Bending Test
Bending mechanical test are performed to evaluate the bending strength or fatigue resistance of the device to bending.

Tensile Strength Test
Ultimate way to test the maximum force of
a product can withstand until reach its weaken point.

Sterilization
A compulsory stages after external sterilization process completed. Sterilization Validation Activities will be implemented to make sure the sterilized products are qualified before hand off to customers.

Printing

 

To provide the best detailed printed on
our products and also fast forward to the latest technology.

- Laser Printing
- Pad Printing
- Injection Printing

Transportation and Bubble Test Validation

 

Transportation Test
Follow ASTM D41659 Standard , Packaging Testing provide assurances that packaging will protect our products from damage or degradation during the transportation and distribution process.

Bubble Leak Test
Follow ASTM F2096 Standard Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization Bubble leak testing is a whole-package integrity test. It is typically performed as part of a validation activity, such as sealer validation, or transit or shelf life simulations.

We build superior quality product that safe and effective.

We build superior quality product that safe and effective.

Wide range of product manufacturing

At Supercomal Medical Products Sdn Bhd, we provide a variety of medical and cabling product that are safe and highly effective. below are the list of products that are manufactured by Supercomal Medical Products Sdn Bhd.

Product Categories

MEDICAL MOLDED CABLE ASSEMBLIES

MEDICAL TEMPERATURE AND SOUND CABLE

COMPLETE CONNECTING SYSTEM CABLE

PCBA AND PROGRAMMING

PLASTIC INJECTION AND BULKHEAD CONNECTOR

STAMPED METAL PARTS AND CNC

TUBING

CARBON FIBER PRODUCTS

DEVICES

MOULDED PART

DEVICES ACCESSORIES CABLE