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Featured Article:

Medical Device and Diagnostic Industry

Innovation in Today's Transforming Healthcare Environment


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Featured Article:

Medical Device and Diagnostic Industry

Securing Today's Healthcare Enterprise Systems


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Featured Article:

Medical Product Outsourcing

Making the Transition from Healthcare Products to Healthcare Solutions


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Featured Article:

Medical Product Outsourcing

More Bang, Less Buck

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Featured Article:

Medical Product Outsourcing

Interview: Under Review - Today's OEM/CMO Relationship

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Featured Article Series:
Medical Product Outsourcing

Rediscovering Systems Engineering in the Medical Device Industry

Today's Daunting Challenge

Medical device and information systems companies are faced with a daunting challenge these days. The increasing complexity and focus on safety standards has ratcheted up the pressure of bringing these complex products to market – on time and within budget. Add to the mix, a rapidly evolving healthcare ecosystem, pressure from all stakeholder groups and the implementation of the Affordable Care Act; and, you're facing some sleepless nights.

It's this type of formidable landscape that Foliage has faced head-on with clients for over two decades. We approach each engagement with a desire to ease our clients' burden. In short, we help our clients maintain focus on their own core competencies – clinical and market knowledge – while Foliage handles the rest.

Foliage collaborates with clients to design, develop and integrate a wide variety of complex software-intensive medical devices and systems. We have comprehensive experience with development standards and processes that comply with FDA 510(k) requirements for the design, development, validation and integration of Class II and Class III therapeutic and diagnostic devices and integrated enterprise systems.

Collaborating and working with your team, Foliage enables companies like yours to:

  • Accelerate time to market
  • Continually adapt to technology advancements
  • Quickly address new or expanding markets
  • Improve product integrity and reliability to meet increased regulatory scrutiny

Sectors Served

  • Diagnostic
  • Imaging
  • Advanced Information Systems
  • Monitoring
  • Pharmaceutical
  • Therapeutic

Our Capabilities

Design, Development and Test Expertise
Complex software and hardware for embedded and mobile devices to enterprise and cloud-based systems for therapeutic and diagnostic devices, imaging and information management systems

Extensive Development Experience
Integration and process standards such as IHE, HL7 and DICOM, and IEC 62304 and 60601, ISO 13485

Full Product Lifecycle Support
Software, electrical, mechanical, enhancements, value and sustaining engineering, and documentation

Our capabilities are delivered within a comprehensive suite of services to improve program predictability and productivity while driving overall product reliability. Our unique combination of consulting and product development services can mitigate your specific system development challenges, allowing you to focus on developing products with a difference and delivering what your customers want, when they want it.

Contact us today and let us show you how we're different.