Another topic that is unique to medical devices include a robust quality management system or ISO 13485:2016 standards. This standard requires that a quality management system is implemented to meet the standards for safety and effectiveness of medical devices. Every…   Read more»

The PDCA cycle varies with different specialties and the companies but the overall principle provides the framework for how problems should be addressed and mitigated. In manufacturing engineering, the Plan phase is usually carried out by process and design engineers…   Read more»

From a business standpoint, having a smaller and more experienced team is better than having a larger team where there is not enough work to go out to everyone. At least where I have worked, there were would be one…   Read more»

Events held in anything considered non-professional, especially in the context of medical industry, can be considered an unreasonable location. Events held in resort locations, exotic destinations, or business’ where the primary context is not known for business should be considered…   Read more»

Verbal contracts are still legally binding if they have elements of validity. The problem with verbal contracts though is that people misunderstand each other causing disputes and other legal problems. I’d say verbal agreements in general are always insufficient and…   Read more»

There are also some restrictions where patients can not give gifts to their physicians to. It carries a risk of subtle biasing to the care of that patient. According to the AMA, doctors are supposed to decline any cash and…   Read more»

The matrix completely depends on the organizational culture, project, and preference of the company overall. Where I currently work, most of the PMs do not have the power to make major decisions on a project without consulting the technical lead…   Read more»

I’d say middle management, which includes any type of manager or director, because they have to maintain the operations of their team. More than that, they have to innovate to improve performance of their organization which can be very challenging…   Read more»

I currently work in a matrix organization as well and the program managers would recruit people from different departments for their program. This organization works really well because there is no need to pay for more than what is necessary…   Read more»

The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and approaches should be taken to minimize the damage it may cause. So, within the acceptance phase,…   Read more»

I’ve seen PFMEA used by process engineers for machines. PFMEA us used to identify the different failure modes for the machine and ways to fix this issue. For instance, some of these issues could include sensor malfunctioning, programming error, or…   Read more»

The validation process ensures that all the customer needs are met so that a successful, good quality, and reliable product is made. Thus, it requires rigorous, well-planned, and well-thought-out tests to test the reliability of the product so that all…   Read more»

Initiating document releases and revisions are a crucial part of an effective quality management of any device. In fact, there is a cycle that every document goes through which includes its creation, review, release approval, distribute training, use, and if…   Read more»

Design Matrix with columns for inputs, specifications, validation, and verification is a good starting point but each device has to adapt to its own design process system and all the requirements included for that device. For example, the design matrix…   Read more»

This is usually written out within the companies mission/vision statement. They really care about the quality of their products, especially in the medical field, so they will take every effort to do each of the steps according to the standards….   Read more»

Some of the design verification plans that is done for companies that manufacture medical devices are to see if that devices meet their design specifications and intended purpose. So this will be tests such as QC measuring using CMMs, optical…   Read more»

That is true. We did follow the design control process for capstone where we first wrote up the customer requirements, design requirements, test plans, and evaluation of the test plans. These are basically the Project Proposal, Design Development Plan(DDP), Design…   Read more»

Compensating participants is a necessary part of any trial but there are ethical concerns that arise under coercion and exploitation. In third-world countries, people who come from a poorer background would be incentivized to take on something just because of…   Read more»

Another main concern that nobody has brought up yet is informed consent. The individuals in the trial should make their own decision about whether they want to participate or continue participating or not. Researchers usually have to write up what…   Read more»