In a previous post, we answered if a medical device design and development plan is a regulatory requirement? As a continuation of that post, this week we are exploring what structure the top-level plan should follow. Alongside the flowchart and other documentation, you will be writing the top-level plan. This too will be a live document that you will be writing alongside your flow chart, Gantt chart, and other supporting documentation. Essentially, this is the launchpad to those other documents and so you would list them as external references.
So, this is the high-level master document that executives can read to understand how much the project is going to cost, how long it’s going to take, and ultimately, if it will be feasible. Typically, a pharmaceutical company will take this document and process it through its financial system to govern the financials, understand the return on investment and market share before deciding whether to progress and plan it into the budget for the next financial year.
There’s an art to writing these documents and remaining concise…
1. Overview:
An overview of the project and its purpose.
2. Scope:
The intended use of the device.
3. Major deliverables
The outputs and deliverables for the project.
4. Exclusions:
These are important to outline from the offset.
5. Assumptions:
It’s fine to make assumptions if everybody involved knows what areas your assumptions lie in. This allows you to evaluate what assumptions were incorrect and spot deviations to recoup some budget when problems arise.
6. Project team/structure:
This gives an idea of who’s working on the project, how big the team is and how the team works together. This is crucial in multi-disciplinary teams or where external subcontractors are involved.
The plan needs to clearly demonstrate who is responsible for what as well as the relationships between stakeholders. This will help prevent finger-pointing when challenges arise.
7. Required resources:
These include the external resources you will require such as your test houses, manufacturers, and validation Partners.
8. Accreditation, documentation, procedures & necessary competencies:
This will demonstrate that you have the right certifications, procedures and a robust QMS system in place.
9. Flow Chart Outputs:
These get migrated into a Gantt chart where you will list all line items and start assigning time and cost to each item. This is where the research as well as discussions with your identified resources will happen to gain costs, timeframes, and other parameters to build into the Gantt chart. The results from the flow and Gantt chart work will usually be distilled into a list of major milestones including information such as who’s responsible for these milestones and, when these milestones will be delivered.
Technical Director
John represents regulatory affairs on the board. He manages our quality management system, as well as ensuring tools and systems are in place for the teams to effectively perform.
John holds a Bachelor’s Degree in Industrial and Product Design along with over 15 years’ experience in medical device development. John has particular expertise in the design, development and industrialisation of medical electrical equipment.
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