The consulting agreement should include incentives such as royalty payments for major contributions to the medical device or the project. A consultant may even create intellectual property for a compa...

Many of the objectives stated in this forum are examples of requirements that companies should measure when approving and evaluating service suppliers for consulting or legal work. Documenting these r...

Verbal agreements can be acceptable when there is evidence to support that one or both parties were providing services and benefiting each other. Records such as emails, meeting minutes, or purchase o...

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 innovation, then its organizational structure can aid in...

Multiple project deadlines and meetings can be better handled with management that has the right characteristics. A matrix organization allows for more people to have a say on what should be prioritiz...

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 otherwise. The ability to work for more than one bo...

Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likelihood of supply chain disruption is higher, and the s...

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sig...

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team must measure the effectiveness of their plan. Resi...

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to ...

Successful process validation is intended to prevent product recalls, as there is evidence that the manufacturing process can be replicated while meeting all the requirements. For an original equipmen...

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can...

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. Therefore, it would be beneficial to consider the r...

The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & effects of the product. External factors like indivi...

Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities before they become greater risks or to find ways for ...