Furley Bioextracts manufactures medical device consumables for brand owners under an ISO 13485 quality management system.
Key takeaways
- OEM (your formula) or ODM (we develop it).
- Certified systems: ISO 13485 is the quality management system for medical devices, supported by GMP
- Quoted per project after your brief.
Contract manufacturing of medical device consumables
Medical device brands are audited on their supply chain, so the quality system behind the contract manufacturer matters as much as price. Our medical device consumables are manufactured under ISO 13485, the international quality management standard for medical devices: documented production processes, traceability, change control, corrective action and records that stand up when a regulator or distributor asks questions.
We work from your design and specification. Pilot samples are produced and checked against your acceptance criteria, responsibilities between brand owner and manufacturer are put in writing, and production runs with batch records and quality control at each stage.
What formats can we make?
- Consumables built to your specification
Which certifications and quality systems apply?
ISO 13485 is the quality management system for medical devices, supported by GMP. It provides documented processes, traceability and change control. Medical devices on the Malaysian market are regulated by the Medical Device Authority (MDA); registration responsibilities depend on device class, so confirm current requirements before launch.
Standards and regulators referenced
- FSSC 22000 food safety certification scheme (Foundation FSSC)
- National Pharmaceutical Regulatory Agency (NPRA), Malaysia
How does a project work?
- Brief: product, format, target market, claims and timeline
- Formulation: your formula (OEM) or our development and adaptation (ODM)
- Samples and approval
- Quotation and agreement, per project
- Production and quality control
- Packing and delivery under your brand
What to include in your brief
- Device description, intended use and your classification of the device
- Specifications, drawings and acceptance criteria
- Materials, and any biocompatibility or testing evidence you hold
- Label, instructions for use and packaging requirements
- Target markets, since registration rules differ between countries
Start your project
Send your brief to [email protected] with the product, format, target market, claims and timeline, or call +603-8724-3280. Order quantities and lead times are quoted per project.
Send your product briefCall +603-8724-3280
See also: all OEM/ODM services, our certifications, the OEM/ODM process.
Frequently asked questions
Is Furley Bioextracts ISO 13485 certified?
Yes. ISO 13485 leads our medical device quality system, alongside FSSC 22000, Food Halal, GMP, HACCP, NPRA and FDA.
Who regulates medical devices in Malaysia?
The Medical Device Authority (MDA). Registration responsibilities depend on device class; confirm current requirements before launch.
What do I need to send first?
Your specification, intended use, materials and target markets. We confirm whether it fits our capabilities.