The Right Solutions and People in Place
You make innovative medical devices, but providing field support and replacement parts for products in global markets is a challenge. By outsourcing your service supply chain needs to Flash Global, you can focus on design and innovation, while we support your global customer base. At the same time, this will help you control costs and improve the customer experience.
We support medical device manufacturers with combined revenues totaling more than $130 billion annually. Companies that provide medical devices for diagnostics, imaging and patient care that trust us with repair, logistics, storage, FDA and trade compliance functions.
Whether you have a workforce of 1,000+ or 50, no medical device manufacturer’s size automatically equates to superb customer support once a product is sold. Your primary focus on product innovation and state-of-the-art manufacturing processes is what got your company to where it is today. After experiencing product development breakthroughs, after-sales support like managing field service technicians and spare parts around the globe seems more like a challenging chore — necessary for ongoing success but not fun to tackle.
The reality is downtime is costly. Not only is your company reputation on the line, but downtime also can have significant cost implications. Your service contract probably includes a warranty and may even include a service level agreement that ensures a high level of uptime. So you need to provide diagnostic services, work on your equipment, and get needed replacement parts into the field quickly to meet your SLAs.
In addition, as a medical device manufacturer, you face complex issues (more than most other industry verticals) related to the RMA process. Items you may have significant challenges around are: reclaiming/recycling used parts and products, cost-effective screen and test services, and stringent FDA compliance procedures.
Medical Device Traceability
Adding to the RMA issues are the varying regulatory, trade, FDA and ISO 13485 compliance issues in international markets. In the U.S., the FDA requires that all medical device manufacturers develop a written procedure for tracking certain medical devices throughout distribution and establish an audit program to ensure compliance. Final distributors must keep records of patient information, and a device must be tracked throughout its “useful life.”
This means your supply chains need to tell you where your devices and their component parts are at any given time, a problem that can be solved only with advanced technology and detailed tracking procedures.
Other global markets impose varying regulations and import duties on medical devices. While international expansion increases market reach, it also increases distribution and supply chain complexity. Traceability requirements expand to include import/export regulations, labeling, and product classification codes.
Keeping up with this maze of regulations can be a challenging, costly task, which is where the experts at Flash Global step in.
How We Can Help
Flash Global takes care of your end-to-end post-sales logistics requirements around the globe, minimizing product downtime, managing spare parts warehousing and reducing total cost of ownership, which keeps your customers happy.
Plus, our Class 1 and 2 medical device support capabilities can help you effectively manage the complex set of compliance requirements you face. For Class 1 and 2 devices, we can attain ISO 13485 compliance and FDA registration for your unique products and customer support needs. This process enables us to operated as a medical device manufacturer on your behalf.
Our services include:
- Spare parts logistics to get replacement parts to the right place at the right time, with minimal overhead and the absolute minimum downtime.
- Dispatching service technicians to quickly address problems.
- In-region and in-country IOR/EOR services that help move spare parts across international borders.
- Country-specific regulatory and trade compliance functions.
- Asset recovery and recycling.
- Rapid support in more than 140 countries.
See our full list of our service supply chain offerings.
Best of all, we’re able to do all of this while reducing your total inventory and support costs. The end result is a smoother, more cost-efficient service supply chain that saves money and greatly improves customer satisfaction.
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