PTC Case Studies CVRx® manages risk and accelerates time-to-market with PTC integrity

	CVRx® manages risk and accelerates time-to-market with PTC integrity PTC

CVRx® manages risk and accelerates time-to-market with PTC integrity

PTC

Technology Category	Application Infrastructure & Middleware - API Integration & Management
Applicable Industries	Healthcare & Hospitals
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Predictive Maintenance Remote Asset Management
Services	Software Design & Engineering Services System Integration
Challenge	CVRx, a medical device company, was developing a second-generation system, XR-1, for Baroreflex Activation Therapy. The company initially used IBM Rational DOORS as the requirements management engineering platform. However, after a year, CVRx needed a more flexible, configurable, and customizable platform that could also facilitate requirements reuse. As the project evolved, the company recognized a need for a broader toolset capable of more than just requirements management. To meet compliance regulations and ensure quality while maintaining an aggressive schedule, CVRx needed a comprehensive solution that could manage its requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, as well as automate compliance reporting. Read More
About Customer	CVRx is a privately held medical device company based in Minneapolis, Minnesota. The company has developed proprietary active implantable technology for the treatment of high blood pressure and heart failure. As a venture capital-funded company, CVRx must move its development projects quickly to clinical trials without sacrificing quality due to long regulatory approval cycles. The company is developing a second-generation system, XR-1, to provide Baroreflex Activation Therapy. The XR-1 System is a Class III medical device, indicating it could support or lengthen human life, prevent a serious health issue, or potentially pose a significant health risk if not properly evaluated. The system is subject to the most stringent FDA regulation and is subject to premarket approval. Read More
Solution	CVRx selected PTC Integrity as its engineering documentation and development platform. PTC Integrity provided the flexibility, configurability, and customizability that CVRx needed. It also facilitated requirements reuse and provided a broader toolset than just requirements management. PTC Integrity could manage CVRx's requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, and automate compliance reporting. The platform also provided traceability between disciplines, which is necessary for effectively managing risk. In 2008, CVRx replaced IBM Rational DOORS with PTC Integrity for requirements management. The scope of PTC Integrity was broadened to include source code management, with ties to tasks and workflow management between requirements and source code. Risk management, development issue management, and standards requirements capabilities were added to the platform. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - API Integration & Management

Applicable Industries

Healthcare & Hospitals

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Predictive Maintenance

Remote Asset Management

Services

Software Design & Engineering Services

System Integration

Challenge

CVRx, a medical device company, was developing a second-generation system, XR-1, for Baroreflex Activation Therapy. The company initially used IBM Rational DOORS as the requirements management engineering platform. However, after a year, CVRx needed a more flexible, configurable, and customizable platform that could also facilitate requirements reuse. As the project evolved, the company recognized a need for a broader toolset capable of more than just requirements management. To meet compliance regulations and ensure quality while maintaining an aggressive schedule, CVRx needed a comprehensive solution that could manage its requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, as well as automate compliance reporting.

About Customer

CVRx is a privately held medical device company based in Minneapolis, Minnesota. The company has developed proprietary active implantable technology for the treatment of high blood pressure and heart failure. As a venture capital-funded company, CVRx must move its development projects quickly to clinical trials without sacrificing quality due to long regulatory approval cycles. The company is developing a second-generation system, XR-1, to provide Baroreflex Activation Therapy. The XR-1 System is a Class III medical device, indicating it could support or lengthen human life, prevent a serious health issue, or potentially pose a significant health risk if not properly evaluated. The system is subject to the most stringent FDA regulation and is subject to premarket approval.

Solution

CVRx selected PTC Integrity as its engineering documentation and development platform. PTC Integrity provided the flexibility, configurability, and customizability that CVRx needed. It also facilitated requirements reuse and provided a broader toolset than just requirements management. PTC Integrity could manage CVRx's requirements, specifications, test cases, change requests, defects, and other documents, processes, and records, and automate compliance reporting. The platform also provided traceability between disciplines, which is necessary for effectively managing risk. In 2008, CVRx replaced IBM Rational DOORS with PTC Integrity for requirements management. The scope of PTC Integrity was broadened to include source code management, with ties to tasks and workflow management between requirements and source code. Risk management, development issue management, and standards requirements capabilities were added to the platform.

Impact #1	Full traceability across critical aspects such as requirements, risks, mitigations, and source code facilitates risk analysis, management, and reporting.
Impact #2	Risk Priority Number (RPN) tracking supports System Risk Analysis and Failure Mode and Effects Analysis (FMEA) and ensures safety and quality.
Impact #3	Use of one platform to support multiple engineering roles reduces cost to implement, maintain, and manage.

Impact #1

Full traceability across critical aspects such as requirements, risks, mitigations, and source code facilitates risk analysis, management, and reporting.

Impact #2

Risk Priority Number (RPN) tracking supports System Risk Analysis and Failure Mode and Effects Analysis (FMEA) and ensures safety and quality.

Impact #3

Use of one platform to support multiple engineering roles reduces cost to implement, maintain, and manage.

Benefit #1	Ability to reuse assets such as source code, requirements, specifications, and test suites (e.g., protocols) enable six-month project lifecycles.

Benefit #1

Ability to reuse assets such as source code, requirements, specifications, and test suites (e.g., protocols) enable six-month project lifecycles.

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Overview

CVRx® manages risk and accelerates time-to-market with PTC integrity

Operational Impact

Quantitative Benefit