The consulting agreement should include incentives such as royalty payments for major contributions to the medical device or the project. A consultant...

Many of the objectives stated in this forum are examples of requirements that companies should measure when approving and evaluating service suppliers...

Verbal agreements can be acceptable when there is evidence to support that one or both parties were providing services and benefiting each other. Reco...

Using the company’s mission and vision statements to decide on a structure is a good starting point. If a company emphasizes helping others and innova...

Multiple project deadlines and meetings can be better handled with management that has the right characteristics. A matrix organization allows for mor...

I prefer the matrix organization due to the openness and collaboration. I would be able to acquire knowledge that I would not have learned in school o...

Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likeliho...

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to ...

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team ...

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope managemen...

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer mus...

Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. T...

The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & ef...

Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities bef...