When hearing we are doing ISO 13485 authentication, Canadian customers are interested and make a note during Musk’s (group CEO) Canada trip to medical device customers this Oct.
“How will the ISO 13485 help you?” Musk asked.
“When we apply for a medical device CMACAS certificate, we need to offer many files, such as the qualification files, product information and medical device parts specification. If the parts are from an ISO 13485-certified supplier, it is usually considered reliable. It will help us improve the pass rate.” the medical device manufacturer customer said.
“Then why didn’t you require the suppliers to pass ISO 13485 before?” Musk wondered.
“Because we will take the quality, price and lead time as the priority. The medical components are a variety of materials and shapes. The suppliers’ scale and capability are not at the same level. Only in case of the same quality control directive special (QCDS) condition, we will take the ISO 13485 certified supplier priority. But it is mandatory for the core parts supplier 13485 certified.” Replied the medical device customer.
Medical industry requirements are usually ignored by specific machinery manufacturers. Medical device manufacturers may find suppliers because of the glass cover of the screen, or a small part of the device. The machinery factory, like us, are easy to meet their requirements. But the machinery requirements are on the surface, they still have deep requirements for the service. If we do not have 13485 experience, we do not know the deep requirements. Even when medical industry customers require 13485, factories will ignore it with no 13485 as an excuse. It is commonly seen as normal in the machinery industry. Customers are hardly to require suppliers to do 13485 because of 1 part or 1 project. Therefore, many medical industry customers are hard to get deep cooperation with this kind of machinery factory. The medical device manufacturers are willing to replace these kinds of suppliers with some new ones with ISO 13485 certified whereas the machinery factory has no sense of the crisis.
As there is more and more medical industry customers in the group business, it is important to set up a team to offer professional service to them. AbleMed is the smallest “child” of the group. Growing up and competing under clear regulations not only respects customers but is also responsible for the whole medical industry. Meanwhile, even if customers have no such requirements, we should follow the ISO 13485 initiatively. “AbleMed protects life” is not only a slogan, but also a mission. If we do not follow the system regulations, it will not become reality. That is why AbleMed founder to import the ISO13485.
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