Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
Transparency & Trust
Whether this is the first time you’ve hired consulting services, or you have worked with others in the past, we will always aim to clearly and concisely communicate what to expect, each step of the way.
Here is a synopsis of what your onboarding experience with us might look like. We know that Decision Makers want clear information before getting on board, which is why we start with a Complimentary Intro Call as an easy first step to dip your toe in before taking the plunge.
We are committed to the highest standards of service; to see our
Quality Policy, Vision, and Mission Statements click here.
How Long Will it Take?
The Timeline to achieve your goals depends on the classification and complexity of your device, structure of your organization, regulatory objectives, and current state of your processes and documentation. We will hold your information in strict confidentiality at each step of our collaboration.
1. Intro
On our initial Intro Call we will spend 30-60 minutes getting an overview of key factors. From there we can give you a projected time range based on the potential scope of the project.
2. Roadmap
After the initial Intro Call, we can recommend options for next steps to thoroughly review your project and goals and finalize a detailed timeline and cost estimate.
a) A remote desktop document review to further explore the current state of the project, goals, and project estimate. For smaller projects, the remote review might be enough to complete our assessment report with cost and timeline estimate. For bigger projects the remote review could be the first step before an on-site visit.
b) A short pre-commitment visit for a confidential on-site Project Definition Review to collaborate with your team and review the current state of your processes and documentation.
After thoroughly understanding the scope and goals of the project we will prepare a detailed and customized assessment report with cost & timeline projections for your goals. This will be the Roadmap for your project and it will be a living document that you can control at each Milestone stage.
3. Implementation
Once you have decided to proceed we will provide a contract for your review and signature, including project Milestones where we provide an 'On-Track Overview' and a project update.
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We confidently and proudly offer measurable accountability throughout the project process, providing higher quality Consulting Services with Cost & Risk Reduction built in at every Milestone stage, where you stay in control of your project.
How Much Will it Cost?
Just as in a Timeline projection, the Costs involved to achieve certification depend on the scope of the project, classification and complexity of your device, structure of your organization, regulatory objectives, and current state of your processes and documentation. We will hold your information in strict confidentiality at each step of our collaboration.
1.
Our Intro Call is complimentary. After this call we can give you a broad range estimate based on the potential scope required to meet all the regulatory requirements for your device and project with an overview of the onboarding process. The information we will gather from you on this call will be handled confidentially and will help us get to know your goals and needs. It will also help us recommend the potential next pre-commitment step for you.
2.
After the Intro Call, we can provide cost estimates for the potential next step such as a detailed review to develop an Assessment Report with timeline and cost estimate. The next step could be a Remote Documentation Review, and/ or on-site Project Definition Review, or combination of both. We will provide up-front pricing for the Assessment Report development steps and options. The Assessment Report will serve as the Roadmap for your project and it will be a living document that you can control at each Milestone stage.
3.
Upon project launch we offer an engagement contract based on the Assessment Report, which will include Milestones and estimated costs for each stage. We will provide an analysis of progress at completion of each Milestone so that you stay in control of your project. We confidently and proudly offer measurable accountability throughout the project process, providing higher quality Consulting Services with Cost & Risk Reduction built in throughout the life-cycle of the project.