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116 SMT Magazine • July 2016 medical device are properly documented. This is ultimately the responsibility of the legal manufacturer but an EMS company will have to ensure that the introduction of any change is properly controlled and documented on their side too. Supplier management is also an important consideration. A medical PCB manufacturer is required to maintain a compliant supply base for components, bare boards and so on. This is likely to involve regular auditing and continued maintenance of an approved vendor list. When planning for the manufacture of medical electronics, cost and budget is a signifi- cant challenge. Investing in facilities, machin- ery, extra staff and everything else needed is a substantial expense. With big outlays comes big risk—in a nutshell outsourcing minimizes that risk and frees up a lot of capital. There are a lot of things to consider when choosing who to work with and it is worth taking time to make sure the partner fits your needs. In the past, many organizations would be tempted by the lowest quote or fastest turnaround, but it is worth thinking more strategically than that. It is important to look beyond the present and ask questions like: If your production increases, could your preferred supplier meet these new demands? What are the benefits of working with a sup - plier with a quality management system (QMS) in place? Safeguarding for the future is paramount. To help you make comparisons between suppliers, ITL has listed a set of questions to ask your prospective medical PCB manufacturer. These will help ensure that the manufacturer you work with has the right experience and ex- pertise for you. Top 10 Questions to Ask Your Prospective Medical PCB Manufacturer When you're looking to change supplier or are outsourcing for the first time, you want to know that the company you are partnering with has the right experience and expertise. So what should your key criteria be for employing your medical PCB manufacturer? Here's ten top things to ask that will help you to easily make comparisons: ONE: What will my order cost and what are your lead times? Cost and lead times are going to be the pri- mary factors in your decision—in our industry everyone's looking to get best value for money and has deadlines to keep. But don't look at these in isolation—it's important not to sacri- fice quality for speed. Make sure you strike the right balance between quality, value and lead times. TWO: What regulatory approvals do you have? A manufacturer doesn't have to have medi- cal specific regulatory approvals such as ISO 13485 if they're only producing the PCB that is integrated elsewhere. However, if they do have a quality management system (QMS) in place, you can be sure that the entire process of pur- chasing, producing, handling and testing PCBs is highly controlled. So, looking for a PCB man- ufacturer with these approvals will give you ex- tra security and protection. THREE: Do you have a process validation procedure? Some subcontract PCB manufacturers will produce straight from your bill of materials, while others validate their processes before they start. Process validation is a way of ensuring high yields before manufacturing starts as op- posed to having to rework boards that fail. What you need depends on factors such as which markets you are selling into (e.g., if you sell your device in the USA, your process will need to be validated to FDA standards). As a critical part of the device, the FDA may want to audit your PCB supplier. FOUR: What level of traceability will my PCBs have? Traceability can range from critical parts to full component level. The level of traceability needed depends on the class of your medical device. For a low-risk Class I device you may only need the critical parts to be traceable and if these aren't on the PCB your manufacturer may not need any traceability at all. That said, it is worth considering the balance between what is required by regulation and what makes sense to HOW TO OVERCOME MEDICAL ELECTRONICS MANUFACTURING CHALLENGES

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