Medical Device Project Management
Your project will be handled in a transparent manner that will allow you and your team to have complete control and visibility in to the work being performed. We specialize soley in medical device project management.
- Prior to project startup up you will work with our team to formalize the project management aspects to be used on your project. You can customize as needed to meet your business goals.
- Our standard engagement will include the following:
- All items developed as part of this project will be given to customer in an electronic manner during the review process, when released, and at the conclusion of the project as part of a design history file.
- Weekly meetings will be held with customer personnel to review progress and work technical issues. Weekly reports will be given to the customer that will include at a minimum; written status reports, budget status, action item status, items completed in prior week, items to be worked in the upcoming week, updated schedule and risk register.
- Sterling will complete the work in phases. Each phase will have interim deliverables to allow for you to review and approve plans, work products as they occur.
- The Sterling Product Development Life Cycle is designed to meet FDA and CE regulations while giving our customers the information and control needed over the product development process.
- We have integrated Agile Processes into our ISO 13485 registered software development processes. This allows you to have maximum flexibility, visibility and control of the very important development process.
- At project completion, a project close out meeting will be held, the client chooses what media format the DHF file should be placed, and the entire DHF, source code, documentation, etc is then transferred to the client.
Please give us a call at 201-227-7569 x2 or click here to meet with our team to get your project issues resolved quickly and efficiently.