In August of 2018 the Food and Drug Administration announced that it will be using ISO 13485:2016, the latest evolution of the International Standard Organizations 13485 standards for medical devices, as the basis for its quality system legislation. This standard, which is used throughout the world, is now the basis for medical device regulatory law in the United States.
Some general requirements of the specification from Section 4.1 are:
1) The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.
2) The organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements.
3) The organization shall determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization.
ISO 13485:2016 specifies controls for virtually everything involved in the lifecycle of a medical device: from design through development and production to final use and servicing. The standard applies to companies regardless of their size or place in the device supply chain. The standard also applies to work on a medical device done by outside vendors or service providers. If your company is certified, then your company is responsible for making sure that all applicable work or parts that go into a medical device product meets the standard. Hence, it is smart, good business to simply deal with other ISO 13485:2016 certified companies.
The Benefits of Certification to Our Customers
EB Industries has been committed to the Aerospace & Defense markets by offering Electron and Laser Beam welding services. To address the highest quality standards in that industry, EBI has gone through the certification process to be AS9100D, NADCAP, and ISO 9001:2015 certified.
Over the years and with the introduction of laser technology at EBI (1984), we have seen the need for a medical device quality certification. ISO 13485 has been a standard in the industry for years yet has normally been used specifically for medical device manufacturers. Since most of our work has been as a sub-contract weld shop for medical devices, the need for this certification seemed to be negligible. With the recent expansion of our services and capabilities, and now that we offer welding, contract manufacturing, and supply chain management of medical devices, the need for this certification is now a strategic and necessary requirement.
If you’re working with EB Industries, you don’t have to worry about whether not we are meeting everything required by the standard. We have been approved by ISOQAR, an accredited certification body. All processes we might perform on a medical device are covered within our QMS, from how parts and materials enter the building to customer communications to final testing and shipment.
You can be assured that at any stage of your product cycle, we are meeting or exceeding the standard.
We’ve welded thousands of parts for devices in the medical industry, and we have the experience (and the certification) to ensure the quality of your product. We also have the technical knowhow and engineering capabilities to help you solve any difficulties you might encounter as you develop your product.
Questions? Talk to our engineering staff at 1 (631) 293-8565. Have an requirement? Submit an RFQ by clicking below.