architecture-2290239_1280.jpg

Customized CMMI-type appraisal for Medical Device industry

NOPMARK Consulting services utilizes the best practices from CMMI for Development to provide a custom appraisal and improvement solutions in areas such as project management, process management, systems engineering, hardware engineering, software engineering, and other supporting processes used in development and maintenance of medical device products. In addition to being customized for the medical device industry, our solution are also tailored for teams using Agile methods.

 
 
 

Phase 1

Over a period of one to two weeks, NOPMARK Consulting will appraise your product development organization on the following areas, customized for the FDA-regulated industry. As part of our tailored solutions your organization can choose all areas or a select a subset based on your specific needs.

  • Causal Analysis and Resolution
  • Configuration Management
  • Decision Analysis and Resolution
  • Integrated Project Management
  • Measurement and Analysis
  • Organizational Process Definition
  • Organizational Process Focus
  • Organizational Performance Management
  • Organizational Process Performance
  • Organizational Training
  • Product Integration
  • Project Monitoring and Control
  • Project Planning
  • Process and Product Quality Assurance
  • Quantitative Project Management
  • Requirements Development
  • Requirements Management
  • Risk Management
  • Supplier Agreement Management
  • Technical Solution
  • Validation
  • Verification

We provide a detailed assessment and all the steps needed to plan and implement an improved development practice. If you choose, we can continue our collaboration and implement those solutions for you in Phase 2.

Phase 2

The detailed Appraisal Report from Phase 1 contains the following topics for each process area evaluated.

  • Weaknesses
  • Improvement Activities
  • General Discussion
  • Recommendations

In Phase 2 NOPMARK Consulting will work with you to implement the Recommendations you select to proceed with. This collaboration includes developing any processes, plans, procedures, work instructions, tools, training, hiring, job descriptions, etc. needed.