Industry Trends
Medical Device Companies Succeed by Putting in Controls
FDA regulatory compliance is one of many business process controls that leading device manufacturers have put into place. Additional controls are necessary to support the entire product lifecycle from design conception through production and post sales support.
Many companies are implementing improvements in their control procedures to support not only R&D, but engineering changes once they move into production or distribution. This insures the accuracy of bill of materials, item numbers and engineering revisions.
These controls are also extended across the customer lifecycle to ensure sales and service people have accurate information that the device can be tracked as serviced and as disposed after it has been shipped.
Automation of systems and replacing paper with one system of record that centralizes information into one source and automates business processes.
This enables the manufacturer to have all the information needed to resolve an FDA audit, speed engineering changes, or address operational issues quickly.
|
|
|
Success Stories:
Artomick
was able to automate business processes and completely eliminate its old system, increase production without adding headcount.
Medtronic Sofamor Danek
develops, manufactures and distributes implants for the surgical treatment of spinal problems, and the instruments needed to make these products effective.
|
|
