Medical Devices Manufacturing

Companies manufacturing medical devices face some of the most challenging operational demands in all of business:
  • Compliance with the FDA and other regulatory bodies
  • Stringent quality assurance requirements and the accompanying product traceability/genealogy capabilities
  • Increasing need for flexibility driven by global competition
These are just a few of the obstacles companies in this industry face, whether they are delivering Class I, II or III medical devices.

Companies in this market require a manufacturing system that has been specifically developed to comply with the FDA's Quality System Regulation (QSR) and ISO 9001/ISO 13485 design control requirements. These requirements are especially tough for companies focusing on high-complexity, low-to-medium volume devices, as is typical among medical device manufacturers. Additionally, CAPA (Corrective and Preventive Action) continues to be an area of emphasis during FDA Inspections and Notified Body audits. An effective CAPA system will enable a company to achieve its compliance and regulatory obligations and improve its ability to meet business goals.

Plexus Online provides a turnkey solution for medical device manufacturers, including comprehensive CAPA functions for internal use and for use with suppliers. Plexus Online also offers the flexibility to provide point solutions (such as the CAPA module) for specific needs in manufacturers who already have established internal systems and processes.