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PLMplus

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FDA Compliance

PLMplus Announces Beta Product for Medical Device Manufacturers

Cloud-based QMS and PLM solution empowers midsize medical manufacturers to meet FDA 21 CFR Part 820 and ISO 13485 regulation.

Published: Thursday, May 13, 2010 - 10:34

(PLMplus Inc.: Framingham, MA) -- PLMplus Inc. has announced the beta release of PLMplus for medical device manufacturers, an on-demand, subscription-based solution that combines quality management system (QMS) and product life-cycle management (PLM) features into a single, integrated, ready-to-use solution.

PLMplus enables small and midsize manufacturers to meet compliance requirements, while providing them with the necessary tools to manage their product development. For medical device manufacturers this means reduced operational costs and faster time to market.

PLMplus for medical device manufacturers features the following QMS, PLM, and requirements definition and management (RDM) features:

QMS features

PLM features

RDM features

Design control

Engineering change management

Requirement definition

Document control

Engineering document control

Requirement life-cycle management

Corrective and preventive action (CAPA) management

Bill-of-material and item management

Traceability

Internal audit

Supplier collaboration

And more

Approved vendor list

And more

 

Audit trail

 

 

Nonconformance

 

 

And more

 

 

“Taking a medical device from concept to production is a challenging process,” says Guy Alroy, CEO of PLMplus. “To support that process, PLMplus integrated the key features commonly found among multiple systems into a single, affordable solution, geared toward small and midsize businesses. We are very excited with the release. When comparing feature by feature, capability by capability, PLMplus provides the midsize medical manufacturer superior value.”

PLMplus is a scalable, affordable, and easy-to-use solution delivered in an on-demand manner. As a cloud-based solution, PLMplus provides a midsize manufacturer significant advantages including no software costs, no implementation expenses, minimum training, and no hardware equipment to purchase. A cloud-based solution also means that collaboration with contract manufacturers, suppliers, and others is done online and in real time from anywhere.

PLMplus uses leading edge technology to enhance usability and enable high grade performance from astonishing data visualization, to the handling of heavy sized data transfer over the web. Developed in state-of–the–art Microsoft Silverlight technology, PLMplus provides a rich user experience in comparison to a standard browser.

 

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About The Author

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PLMplus

PLMplus provides a solution coupling quality management and product lifecycle management, delivered in an on demand model. PLMplus is the only solution that provides small and medium companies with the ability to start with a small and simple system implementation and grow only according to their needs. PLMplus is backed by the leading venture capital firms Hasso Plattner Ventures and Cedar Fund.

More information on PLMplus Quality Management System and Product Lifecycle Management solutions can be found at www.plmplus.com/category/Products.