For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it co...

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for ...

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the...

Cross-functional teams are essential to many projects, and omitting a sequence of activities can significantly impact their purpose. The purpose of these teams is to allocate project resource effectiv...

One way to make sure that all project documents remain accurate and update is by maintaining and utilizing version control software, along with access control. As mentioned, suppliers and manufacturer...

An important factor to consider which is equally important as pre-market approval is post-market surveillance of medical devices. A rigorous and well-made pre-market portion of a medical device projec...

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As mentioned before, a RACI can certainly help decrease the ambiguity associated with the development of a syringe that does not leak and clump. However, a RACI does not directly address the risks tha...

Designing a risk assessment properly by taking into account all the details that can contribute to risk in a project can help strengthen a verification protocol considerably. Identifying errors or pot...

One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA and the EUMDR have different processes when it co...

Curing patients could be a sustainable business practice, however it does not seem reasonable. With a business model that prioritizes curing patients, a plethora of ethical dilemmas could come into pl...

One important aspect of task scheduling that hasn't been mentioned is the important of incorporating slack when scheduling tasks. Slack is important to a project as it allows for a project manager and...

Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (usually). Increasing scope can also alter the timeli...

A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 knowledge areas and coordinating all elements with...

In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often overlooked by many as risk management may not be ta...