Your ISO 13485 Medical Device Contract Manufacturing Partner
* patient positioning
* surgical drapes
* fluid management

Quantities from thousands to hundreds of thousands, highly scalable.

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Proven Quality, Made in Malaysia

Millions of our products have been used in the USA, Canada, Europe and around the world!
Friendshoring has its benefits- quality, price and scalability.
ISO 13485 certified & FDA registered.
Qualified supply chain from across Asia including SE Asia, Korea and China as well as Canada & USA.

Materials & Processes

Wide range of foams including laminated, EVA, PE, PU
Webbing, hook & loop fasteners, mesh
Plastic films including PE, TPE, PVC
Injected plastics
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Assembly

* sewing & stitching including automated pattern stitchers
* die cutting
* adhesives
* heat sealing
* calibration
* labelling

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Plastic Film Welding

* HF High Frequency/ RF Radio Frequency welding
* Heat sealing
* Ultrasonic welding

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Inspection & Quality Control

* ISO 13485 certified
* inbound, in-process, final inspection
* AQL sampling through 100%
* destructive testing
* external test labs
* destructive testing

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Contract Manufacturing

You own the design, we manufacture, inspect, package & label per your specifications.

Design Support

We support your design team including material samples, product samples, lab and certificates.

FAI Samples

Samples for First Article Inspection (FAI) are critical to the quality process and success of new products, and transferred products. Once a new product is approved we recommend carefully ramping up volumes.

IQ/ OQ/ PQ

We support the usual processes including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Intellectual Property

We fully respect your legitimate rights to your intellectual property and require confidentiality agreements with our suppliers and providers, and maintain strict control of drawings, processes and specifications.

Scalability

We can rapidly scale to your requirements. We had a customer during the pandemic introduce a new product and we scaled it up to 6 40-foot sea containers per week within a couple months!

Why Choose Us

We have manufactured and sold over a million medical devices, enabling our customers to grow profitably. We focus on quality and customers. Our wholly owned and managed factory in Malaysia provides high quality, low cost and high scalability. We have senior personnel with decision making ability in North America to support you.

Partnership

We strive to be your trusted partner, fully meeting your needs and expectations. Honest, direct communication, in English.

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Proven Quality & Value

Our cost and quality are proven over millions of products over two decades.

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Scalability

Demand changes, and we can respond to your requirements. Start small, stay small, grow fast- we can handle it..

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Request a Quote Today

Reach Us

Email:

info@mapletreeglobal.com

Phone:

+1-778-557-1800

WhatsApp:

+34-647118237

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