In projects related to medical devices, operations are executed based on ISO 13485—a quality management system (QMS) certificate. Here, a practitioner shares his design philosophy for setting up a QMS for a MedTech startup.
Find answers to these questions and more in this Quality Practice Area. If you are new to Quality, take advantage of the resources below and don't be shy about commenting or asking questions. If you're a seasoned pro, help others out and become an influencer. We welcome contributions from all sources and the more you participate, the more visible you become. Let us help you move down the road from "giver of sage advice" to "Thought Leader".
44
Votes: 6
6
caroline maurercaroline maurer replied Nov 24, 2023
2
Votes: 0
0
Keith NovakKeith Novak replied Nov 6, 2023
1
Votes: 1
1
Robert WitvlietRobert Witvliet replied Nov 5, 2023
26
Votes: 1
1
Edward CalllaghanEdward Calllaghan replied Oct 24, 2023
1
Votes: 0
0
Rami KaibniRami Kaibni replied Oct 18, 2023
32
Votes: 1
1
ISHAN THAKARISHAN THAKAR replied Aug 30, 2023
1
Votes: 0
0
Verónica Elizabeth Pozo RuizVerónica Elizabeth Pozo Ruiz replied May 17, 2023
10
Votes: 0
0
Latha Thamma reddiLatha Thamma reddi replied Apr 12, 2023
12
Votes: 0
0
Latha Thamma reddiLatha Thamma reddi replied Apr 12, 2023
7
Votes: 0
0
Latha Thamma reddiLatha Thamma reddi replied Apr 10, 2023
Network:0
Network:293
Although they may appear to be competitors, Agile and Lean Six Sigma have the same objective: supporting the organization’s priorities by achieving customer satisfaction. Lean Six Sigma has a very mature approach to process improvement: DMAIC (Define, Measure, Analyze, Improve, and Control). This approach can certainly be used for a successful Agile transformation. The webinar is based on the author's experience using the Lean Six Sigma DMAIC framework for Process Improvement for software development projects with a focus on D (Define).
‘Scaled Agile’ is one of the most misunderstood concepts. Agile adoption surveys indicate that Scrum, or some combination of it, is used by 70--80% of Agile Teams. None of the 'scaled' frameworks is mentioned as 'used', only as an option to 'scale'. Agile, a new approach in 1970 to scale down manufacturing processes and make them more ‘Agile,’ was created to improve Lean Six Sigma. Out of Software development, the team frameworks are now 'scaling up' by reverting to Lean Practices like Kanban, Theory of Constraints, Voice of Customer, Kaizen, etc. The Six Sigma component that is the most mature and confirmed way of measuring the impact of process improvement initiatives was left out. This is possibly partly because it requires skills and knowledge that can't be acquired in a 2-3 days course, partly because its practices are associated with manufacturing, and it is as seen incompatible with software development. In addition, Lean goals (eliminate waste, adoption of standardized processes) are completely opposed to the Agile mindset that fundamentally embraces change, allows good waste, and is against reliance on standardized processes, This webinar is an analysis of lessons learned from using Lean Six Sigma to measure process improvement initiatives in software development including a comparison between Agile and Planned approaches in a large system development. It is a project manager's view that is probably different than what is heard in conferences and training courses.
This simple tracker for software projects logs project status, review summaries, and important events. The sheet maintains resource utilization cost and completion percentages, ensuring that projects are within budget. The simplicity of the presentation helps the template be easily presented to higher management.
This template provides a framework to communicate your project's purpose (with some supporting information) to the project team. It should be completed as soon as the project is approved and should be led by the sponsor. It will require input from multiple stakeholders (including the project manager), and should be walked through with the team as part of project initiation.
The Final Project Performance Report is developed in the closing process. It documents final project performance as compared to the project objectives. The objectives from the project charter are reviewed, and evidence of meeting them is documented. Use this form to document your progress.
While actively participating in mentorship during a project with a local design/build firm, this practitioner compiled an overview of the project management process as detailed in PMI’s A Guide to the Project Management Body of Knowledge (PMBOK® Guide). Use this overview with other project managers as a tool to reference in your day-to-day PM activities (as well as share with new project managers).
Use this Go/No Go production readiness checklist to assess if your organization is prepared to deploy an application. This spreadsheet aims for a composite or holistic view between the business and technical aspects of an application deployment. There are 36 questions in nine categories to respond "yes" or "no" to, with self-adjustable weighting and a final score.
The trade-off between project delivery time and quality often depends on the specific requirements and constraints of the project, but this is not always something that’s properly assessed. When push comes to shove and you have to decide, which side should you pick?
This article draws on well-known, basic project management concepts to introduce the high-level project management concepts of defined and empirical process control. It also attempts to contrast them and suggest how they might be used by PMPs in practice.
Due to the nature of the regulatory landscape and the complexity of the healthcare system, MedTech startups experience a higher level of uncertainty and risk. This PM shares his first-hand experiences from a startup launch in this sector.
When project teams are buried in the details of their work, it’s easy for them to forget that they are producing solutions for real people. PMs need to help them remember.
Test-driven development is an important part of ensuring that software can be effectively evaluated before it is deployed to embedded systems. Program managers must be prepared to accommodate additional test time—and champion the creation and maintenance of custom test platforms and tools.
Managing a capital project is not for the faint of heart. Navigating the complex web of planning and execution requires an understanding of many aspects in the project delivery lifecycle. One key approach for PMs is to focus on achieving operational readiness once the project is complete.
The growth of agile and the increasing pace of all forms of project delivery have meant that the triple constraint is no longer the thing we all have to tattoo on our brains. But it is still important, and it is still heavily misunderstood. If it’s not helping, then it needs to adapt—and a new variable can help.
Accreditation offers periodic self-evaluation, assessment and improvement opportunities for the educational institution. Higher education institutions should handle accreditation projects with utmost care—and use it as a chance to refine their plans to offer the best services for their students and community.
If what we measure prompts change, then we have to be careful what we evaluate so that attention is focused on those things that are most meaningful and important. We are exhorted to “measure what matters” with “key performance indicators"—which often miss the mark.
"We need to guess if we are successful?!” They often get a bad rap, they’re often misunderstood, and executives frequently want to avoid them. But subjective performance measures help when there simply isn’t a way to know whether benefits have been achieved.
|
"Technology is a gift of God. After the gift of life it is perhaps the greatest of God's gifts. It is the mother of civilizations, of arts and of sciences." - Freeman Dyson |
