Medical Device companies of all sizes face a competitive marketplace where it is vital to deliver innovative new products while delivering compliance with increasingly FDA and other regulatory regulations. SmarTeam PLM and Design Rule’s best practices provide manufacturers with the tools they need to ensure a successful FDA and ISO compliant product rollout. Whether you are in medical device product development or other life sciences business.

SmarTeam PLM enables closed loop, root-cause analysis when implemented with fully integrated product, process and quality documentation along with BOM Item Master data.

SmarTeam’s unique configuration flexibility enables the creation of contextual links and references between data and documents to be established; to more realistically represent your product and NPI processes though their lifecycle than any ‘document’ management system – this is the true value of integrated PLM

Dozens of medical device manufacturers and and pharmaceutical companies worldwide depend on SmarTeam to:

• Speed compliance with FDA regulations including Title 21 CFR Part 11, which prescribes the accepted use of electronic records and signatures in medical device manufacturing
• Achieve cost and time savings through efficient re-use of Intellectual Property (IP).
• Reduce overall engineering time through one cohesive solution that allows management and collaboration of design information and visibility into the complete product development process.
• Improve global new product introduction processes to drive profitable growth through cycle time reduction and increased resource productivity
• Consolidate supply base and develop strategic suppliers and partners
• Emphasizes process definition - improve common enterprise processes, then track and measure those processes as a basis for improvement

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