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White Papers & Case Studies

A leading, international medical device company, partnered with SPK to enhance document change control, as well as enable collaboration between international offices. The acquisition of a European company created gaps in the organization’s architecture, inhibiting effective communication between engineers in the US and Europe. Because the two divisions use different sets of standards, thorough documentation was paramount. The following provides details regarding SPK’s solution including the benefits, process, implementation and results.  

Case Study: The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction

A diversified medical device company with a leading position in the global endoscopy device space had concerns about a key product. As new technologies hit the market and client expectations grew, the company’s top endoscopy medical device began to reveal its inefficiencies. SPK recommended cloud-enabling the device so sales and support services could remotely manage and maintain the complex settings on new, existing and replaced devices. Learn how SPK helped the company take the industry’s best practices and create a sustainable, cloud-enabled product.

Case Study: How to Use DevOps and Cloud to Rapidly Respond and Scale

Download a case study about a health insurance software company in need of a more effective DevOps process and production cloud architecture. You’ll learn how SPK helped the client achieve these outcomes:

  • Acceleration of build-release cycles by 400%
  • Full automation of HIPAA-compliant builds
  • Significant decrease in server environment replacement time
  • Fully redundant Production environment on a cloud infrastructure
  • A Jenkins registry of all objects on a S3 data store
  • A more robust, secure operating environment that improves efficiency, lowers costs


White Paper: Leveraging PTC Integrity for IEC 62304 Compliance

SPK and Associates leverages PTC’s Integrity platform to provide complete end-to-end requirements traceability, tests management, defect tracking, risk and hazard management, SCM, and cross activity metrics for your projects. This collection of capabilities under a unified architecture help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.

White Paper: Dassault Enovia Integrates Product Innovation with Quality and Compliance

SPK and Associates has developed both fully hosted and Rapid Deployment “Licensed to Cure” solutions that are tailored to the specific needs of small and medium businesses. With highly configurable functionality bundles, the SPK’s Acceleration Process Library can be implemented 3 to 5x more rapidly at a price point that works.

White Paper: Beyond Compliance How PLM supports a successful TPLC deployment

Despite a global recession, medical device manufacturers are facing an unprecedented opportunity for growth. High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions. Yet rising costs and compliance concerns are dulling those opportunities, forcing medical device companies to proceed with caution —balancing the competitive drive for product innovation and quality with reassuring consumers that what they buy is safe and fairly priced.

White Paper: Bridging the gap between compliance and innovation

Success in medical device manufacturing requires continual innovation in order to deliver improvements in the quality of patient care. This in turn drives business revenue and profits. At the same time, device manufacturers need to comply with the extensive quality systems regulations as issued by the Food and Drug Administration (FDA) and other regulatory bodies and standards organizations.

White Paper: Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit

The medical device industry has always been dependent upon product innovation to drive growth. With today’s aging global population and expectations for living to an older age, the medical device industry is poised for a sustained period of extreme growth fueled by a level of innovation that is scheduled to accelerate. Most companies are growing. Nearly all are innovating at an increasing pace. The common challenge is how medical device manufacturers and their suppliers can simultaneously improve their financial performance, product innovation and quality while growing at a significant speed.

SPK & Associates

20 S. Santa Cruz Avenue, Suite 300
Los Gatos, CA 95030
Phone: 888-310-4540

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