Thinking March 31, 2021

The Benefits of Transferring Your Medical Device Project to Malaysia

By
SteriPack

There are lots of reasons for wanting—or needing—to transfer your medical device project to a new contract manufacturer.

But with so much on the line, how do you ensure a seamless transition from either internal production or an existing contract manufacturer to a new one? Factor in things like geography, logistics and capabilities—not to mention cost—and your project transfer can get even more complex.

For the past few decades, China has been the manufacturing location of choice for outsourcing low cost, complex assembly medical device products, such as dialysis kits, catheters, and vascular and wound care products. Recently, however, other Southeast Asian locales have proven even more beneficial for outsourcing.

Ensuring global regulatory compliance and high quality assurance standards are critical to the success of your product or medical device. Anything less than 100% compliance and QA is simply not worth the risk.

Fortunately, you have options, including a more cost-effective and risk-averse location in the APAC region. We’re talking about Malaysia.

With multiple shipping ports and international airports, plus access to an abundance of locally sourced raw medical device components, Malaysia is uniquely situated as a hub for manufacturing and commerce.

We were so impressed with the concentration of medical device manufacturers in Malaysia that we built our own 86,000 sq ft facility there in 2007, complete with a state-of-the-art 24,000 sq ft ISO Class 8 clean room to manufacture sterile, single-use medical devices. We think you’ll agree, SteriPack Malaysia is a smart choice for your project transfer.

SteriPack Malaysia is conveniently located a few hours from Singapore and just 4 miles from the nearest port. But most importantly, the facility adheres to standardized processes and quality standards that stem from over 20 years of experience and best practices used across SteriPack’s US and European sites.

As a member of the Association of Malaysian Medical Industries (AMMI), SteriPack Malaysia is a highly regarded contract manufacturer in the region. We’re ISO 13485 certified, and FDA registered and audited with no critical observations. And with our diverse, English-speaking European and Malaysian management team overseeing all aspects of your project, from injection molding and assembly to sterile packing and shipping, there are no communication hurdles in the way.

Our production lines are operated by skilled employees who are dedicated to strict compliance and rigorous standards of quality and consistency. Concerned about disrupting your supply chain? Not to worry, we can keep that running smoothly, too. Our experienced project transfer teams have a proven track record of success, navigating even the most complex transitions and product localizations.

Serving both as a finished medical device manufacturing location and sub-component or sub-assembly manufacturing site working with sister sites in the US, Poland and Ireland, our Malaysia facility is an ideal option for complex supply chains requiring sourcing in multiple global locations.

Ensuring an optimal project transfer from anywhere in the world is a top priority at SteriPack Malaysia. You can trust us to not only meet your needs, but exceed your expectations regarding flexibility, cost competitiveness and speed of project delivery—hallmarks of SteriPack’s values.

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