Project Management
Confidence from Start to Finish
Whether you’re designing a novel medical device or transferring an existing production line, the mission of our project management team is the same: we make it easier to get your product to patients. Your QTS project manager will lead every step of the process, from quoting and project planning through first human-use builds and the transition to routine production.
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Your Project Planning Partner
When you work with QTS, we’ll gather details about your product and your needs for packaging, final cleaning, cleanroom assembly, sterilization, and supply chain management. Whether you have a complete package design and all requirements defined, or need help with a complete project plan, we are ready to assist you with the next steps.
Based on the details of your product and requirements, our team will prepare a customized, no-cost, no-obligation project plan proposal with all of the detail you need to make a confident decision. We will provide a preliminary package design, process flow, and get quotes from suppliers, so you get a complete picture of what your product needs.
Your project plan is developed by the same team responsible for its execution, ensuring alignment from the start. At QTS, we prioritize transparency, setting realistic expectations and addressing all critical details up front so you have a clear and accurate understanding of what your product requires.
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Our Phase-Based Model
We know speed to market is key to your success. While a project can have dozens or even hundreds of individual order lines and activities, we structure our projects around 4 phases. We keep things simple by quoting, billing, and invoicing per phase, instead of per activity. We designed our phased process to prevent the cycles of stops and starts that slow projects down, to minimize administrative overhead, and to provide meaningful milestones that keep project teams focused and moving forward.
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Phase 1: Project Planning and Design
Following proposal acceptance, we bring your team and ours together to align on product requirements, finalize the project timeline, and define the validation and sourcing plans. This is where we establish design inputs and commit to shared expectations, so there are no surprises downstream.
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Phase 2: Validation Readiness
Once we are aligned on the project plan, we procure all materials required for the agreed-upon validation requirements. While parts are in transit, our internal teams draft validation protocols, build work instructions, and prepare for validation builds. This approach saves valuable time and keeps the project moving.
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Phase 3: Validation Execution
We release validation builds to production and coordinate all downstream activities: cleanroom assembly, sterilization, distribution simulation, and lab testing. We handle the logistics, timelines, supplier management, and help you interpret validation data.
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Phase 4: Design Transfer
With verified data, we complete validation reports, finalize documentation, and publish clear, production-ready instructions. We tie up all remaining project tasks and ensure a seamless transition, positioning your product for consistent, uninterrupted manufacturing.
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Our Project Planning Framework
We have managed new product launches with hundreds of customers, and we understand your need for information and visibility throughout the process.
This framework provides you with the information you need to make decisions with confidence, from the initial project proposal and throughout the process. Our process has been designed to meet your needs for transparent, complete, and up-to-date information.
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Non-Recurring Engineering (NRE) Plan
A complete plan for all validation, quality, engineering, and other up-front activities. This gives you full visibility to the expected up-front costs and activities for the entire project. In our proposal we provide a complete project plan tailored to your project and known requirements down to the individual sample sizes. We’ll collaborate on and maintain the plan throughout the project.
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Timeline
You need to have constant visibility when your product is going to launch. For every project we maintain a complete, detailed project timeline for the entire project. We ensure everybody knows what is needed and when, and ensure you can plan ahead with confidence.
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Product Requirements
Your product requirements include the bill of materials, all end-of-line operations, and your quality requirements. We review these regularly to ensure we are continually aligned on what your product needs. You don’t need to know exactly what end-of-line services, package design, or sterilization modality is best for your product. We’re experts in helping customers determine their package design and end-of-line processes from the ground up.
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Production Price
Your long-term pricing should never be a surprise. We provide and maintain transparent pricing for your project and keep it up to date even if plans change.
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Let’s Get Started
Choosing a partner for medical device end-of-line processing is a long-term investment. Start with a partner you can trust.
Contact us today so we can start the project planning process with you.
