Many injection moulding suppliers today have the ability to provide manufacturing services to the medical industry. But, is there more than just having injection moulding machines?
We have summarised 5 key things to consider when choosing a medical injection moulding supplier for your medical components and medical devices.
Depending on the product requirements, having suitable environment controls are important. Certain products are required to be manufactured in a clean room (like our Class-8 clean room), some in a controlled environment whilst others can be manufactured in any normal factory floor. It is essential to define this when searching for a medical injection moulding service service provider as cost and quality may vary.
2. Validation process
The IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) process basically ensures that the the medical injection moulding process meets the quality acceptance criteria for the product. Whilst not all medical device requires this validation process, it is important to specify any requirement to the supplier up-front. This is to ensure that they understand the requirements of the validation process and provide adequate attention to this while developing the manufacturing process.
3. Certification of the medical injection moulding partner
When considering suppliers, have a look at their quality systems. the most basic ISO 9001 certification should be mandatory to ensure that the supplier has an adequate Quality Management System. Depending on your requirements, medical devices that require FDA approval or more stringent quality requirements, ensure that they have ISO 13485 and are up to date. Not all medical injection moulding requires ISO 13485, therefore be sure to tell your medical injection moulding partner the requirements up front.
4. Suite of capabilities
For most medical device manufacturers, it is important to ensure that their vendors are robust enough to have most processes in-house. This applies as well to the medical injection moulding vendor. While engineering skill-sets, like the ability to carryout design for manufacturability (DFM), mold / tool making and project management is important, also ensure that they have ability to do secondary processes. This includes having processes like liquid silicon rubber moulding (LSR), printing, ultrasonic welding and assembly. The less outsourcing, the better to ensure processes and quality is controlled.
We cannot stress enough the importance to have data. Whilst traceability is part and parcel of ISO 13485, having a Manufacturing Execution System (MES) helps the capturing of data in a more autonomous manner. Having a stable Enterprise Resource Planning (ERP), Document Management System (DMS) and data security policy and procedures will greatly help ensure digital security, traceability and storage of documents. Hence, choose a vendor who is willing to invest in these systems to ensure that your supply chain management can be digitalize in the future.
Medical injection moulding with us:
- Our plant in Penang, Malaysia is a certified ISO 13485 company and has a Class 8 clean room along with a control room. We have manufactured in this plant for the medical industry for over 10 years. We currently produce plastics for various medical equipment and single-use devices.
- Our plant in Johor, Malaysia has manufactured plastic enclosures for medical equipment for over 5 years.
Contact us now to understand better how we can help you with your medical components.