ISO 13485 & FDA
What We Do
We contract manufacture your medical devices (or components) for you per your drawings, specifications and quality requirements. We procure the materials, design the manufacturing process and tools, manufacture and inspect the products then prepare them for shipping.
We are ISO 13485 certified by BSI and are registered with the FDA as a contract manufacturer.
Our factory is based in Malaysia because of the excellent workforce we have built there, the cost effectiveness of our factory and suppliers and the quality we deliver. We work in English internally and with our customers. We are located within an hour’s drive of Singapore- a world class logistics hub.
What We Do
You provide drawings, specifications, quality requirements and (if available) product samples then you review our FAI (First Article Inspection) samples and if they are right you start ordering. You are the product owner, put your brand on the products and manage your regulatory responsibilities.
Quality
Quality is not a process or a material, but a culture and present in everything and everyone around the factory. All inbound goods are inspected, work in process, finished goods, and shipments. But quality starts before the first product is manufactured and considerable effort is required to design quality into the materials and processes and inspections- before it ever becomes a product.
BSI is our ISO 13485 auditor.
New/ Transferred Products
We believe in a thorough, but fast, approach to transferring products which is easier with an accurate drawing package and several samples. We cooperate on decisions to ensure the optimal results, then provide samples for your approval.
Design Support
Optimal designs require coordination with manufacturing from early on, and we are experienced working with your design team to determine materials trade-offs (e.g. price vs performance), samples, processes.
Established Products
Once your product is ready to manufactureg- you just order and we can handle the rest. Provide us with a forecast and it gets easier, but as markets change we can work with you to ensure rapid scalability.