Some of our consultants come out of the medical device industry in China, the US, and Taiwan. The most common issues we work on are listed below:
Quality issues stemming from a lack of understanding of standards & regulations and/or from poor management.
Rising costs due to poor organization of production, excessive office costs, and so forth.
Here are typical ways we work with medical device manufacturers:
ISO 13485, as well as the FDA Quality system regulation (QSR) and FDA 21 CFR 820, have very specific requirements when it comes to the design & development process of new products. We can help you ensure that process validation is performed as required in all its components (design, installation, operational, and performance).
We also pull from our experience in the automotive and consumer electronics industries. We can help structure your NPI process in a way that makes sense in your company. This way you will develop products faster and more efficiently.
Some of our consultants have been helping manufacturers get certified to ISO 13485:2016, FDA MDSAP, and more recently EU MDR 2017-745. In some cases, the best is to develop an integrated QMS that satisfies all these requirements, while also following the risk-based approach of ISO 9001:2015
If you plan to set up your factory in China to manufacture medical devices, we can help you understand the pros & cons of trying to sell into China. We can help you find the right site, plan for construction and do project management, and help you set up the layout & processes as well as hire the right workforce. And we can accompany you during launch.
We have helped clients work with the local government and submit all the necessary information to get the license to manufacture this type of product.
Respect of specifications is extremely important for medical device manufacturers. You want to avoid inconsistent quality as well as failures in the hands of users. We can help you put in place statistical process control, mistake-proofing devices, and so on.
You have probably purchased expensive equipment. A common problem in China is poor maintenance (waiting until it is broken to work on repairs), and it impacts costs as well as quality and delivery times. Our engineers can put a strong preventive maintenance system in place that keeps your equipment up and running.
Are you suffering from increasing price competition from local manufacturers? You need to raise efficiency in your operations. We can achieve that goal by re-arranging production lines and applying industrial engineering tools, as part of a wide lean manufacturing program.
Are your suppliers the source of certain quality issues? You can hire CMC to implement a strong quality system in their operations. This way you don’t need to spend a lot of time checking, reworking, or sending back their products/components. You can receive better quality, more often on time, and avoid disrupting your operations.
Overall, CMC helps medical device manufacturers improve their product quality while reducing costs (or increasing capacity without any further investment).