Following the responses made above, ISO 14971 is an internationally recognized standard for risk assessment that both the US and EU use. ISO 13845 is a specific type of risk assessment standard that highlights the requirements for quality management systems…   Read more»

Based on the question asked in the title, it is absolutely necessary for medical devices to have risk assessments. The risk assessment is conducted in accordance with international standards such as the ISO 14971: Medical devices – application of risk…   Read more»

The purpose of design control is to create a structured method of managing the design and development process of the product being made. There are several ways design control can be conducted. Design control helps define the requirements of the…   Read more»

A project proposal should include an executive summary, where a brief overview of the project is discussed. It should also include the business needs for the project as well as the objectives of the project. Next, the proposal should include…   Read more»

When it comes to significant errors found in design input documents (DID) or design specification documents (DSD), several steps are often taken to rectify the error. First, the error must be identified. Then a change request (to fix the error)…   Read more»

You are correct in the sense that every input in the design control process should have an output. However, some companies do not and one of the reasons could be because of the simplistic nature of the medical device at…   Read more»

The first and most important part to implement would be to create a well-structured and communicated process for the change that will be occurring. This can be done through several steps starting with outlining the process that will be implemented…   Read more»

The medical device that I will be discussing is the digital blood pressure monitor. The functional requirement of this device would be that the device should accurately measure systolic and diastolic blood pressure values and accurately output the heart rate…   Read more»

Phase 2 of a clinical trial is crucial for testing new medications. It is during this phase that researchers observe the effect of the drugs being tested on a small group of people for an extended period of time. This…   Read more»

A specific testing used in clinical research within the medical device industry is the Premarket Approval (PMA) process. The purpose of this process is to evaluate and ensure that the medical device at hand (a life-sustaining device) is safe and…   Read more»

Following the previous reply, having a double-blind clinical trial would reduce any bias seen in a research study. To conduct a double-blind study for research regarding fibroids in black women, the following study can be conducted:  First, participants would need…   Read more»

For the scenario of stents, here is a SWOT analysis: Strengths: since there is a large need in the US for improved stents, this start-up company has a substantial growth opportunity for reaching its targeted audience.  Weaknesses: there would be…   Read more»

Recruiting diverse and underrepresented populations for clinical trials is crucial for the development of equitable healthcare solutions. It can be challenging to do so in a proper fashion. If I were in charge of marketing and recruiting for clinical trials,…   Read more»

I believe that medical device development industries use targeted digital marketing strategies of advertising on select channels to reach a target demographic/audience. By doing so, companies can tailor to the needs of the specific demographic and promote their products to…   Read more»

Limited Liability Companies (LLCs) and Limited Liability Partnerships (LLPs) are both legal business structures that provide liability protection for their owners. A choice between LLC and LLP depends on the specific needs and goals that the businesses have in mind.  For…   Read more»

When it comes to corporations and considering them as moral entities, there are various points of view that should be taken into consideration. From a legal status point of view, corporations are viewed as moral entities for this specific reason:…   Read more»

I believe additional business courses should be available as electives rather than required courses. Engineering students can follow many different career paths that may not include the need to incorporate business courses. For example, students who are pre-med or are…   Read more»

I believe that involving clients in the developmental stages of a medical device can be highly beneficial. Some reasons as to why include, the implementation of user-centered designs, having early feedback in the process, and having market insights. Having clients…   Read more»

Quality assurance (QA) and quality control (QC) are crucial aspects of medical device development. 2 factors that influence QA are regulatory compliance, ensuring that the device is compliant with regulations and standards, and documentation/training, adequately documenting the process and providing…   Read more»

The responsibility of addressing a damaged label depends on several factors on how the damage occurred. For example, if the damage occurred during handling/shipment of the product then it would be the store’s responsibility to address the issue. However, if…   Read more»