This training has been quite beneficial in showing folks what might be expected of them in the real world. It was interesting to observe the many stages of medical device development and what is requi...

It seems logical to me that these rules are in place. You could think it's a little too limiting, but they need to be there. My father was a doctor in India, and he told me stories of the perks that t...

It seems logical to me that these rules are in place. You could think it's a little too limiting, but they need to be there. My father was a doctor in India, and he told me stories of the perks that t...

When deciding which organizational structure is ideal for a company, the size of the company must be taken into account. The organizational structure largely impacts departmental communication, which ...

I would suggest establishing the startup company as a functional organization from the outset. As stated in the lecture, this type of structure is appropriate for small businesses, and the benefits ar...

It's critical to hire the proper personnel for a successful project team. Professional performance, as well as personal traits, must be evaluated. We often have little control over who joins our team....

The prototype system is being exploited in product development since it does not consider important risk factors. I learned about this risk management blunder at the organization where I work, and I'm...

Additional criteria should be considered when calculating the risk value. In most cases, EDP audit teams search for both threats and vulnerabilities in corporate information systems. This usually take...

In my perspective, risk management starts with end-user training and education. It is incumbent to a corporation to educate the end-user population to the best of their ability once they have done all...

Validation is necessary to verify whether the gadget satisfies the user's demands and is fit for its intended purpose; it also aids the corporation in determining whether they are building the proper ...

One of the benefits of the DID document is that it gives you a broad idea of how the finished product will look. This is essentially a mental image of what you and the department think the design will...

The Turkish Medicines and Medical Devices Agency is in charge of design control in Turkey. It adheres to ISO 13485 and ISO 9001 standards. Medical devices in Turkey must be CE-marked and registered in...

One thing I've learned is that no matter how much planning you do, some situations are beyond your control. In my field, for example, we must do multiple pre-clinical experiments, which must be coordi...

The FDA mandates design controls, which are used to assure traceability of issued products. The notion is that if a released product has a flaw that interferes with its operation and has an impact on ...

Meeting minutes are indeed a significant element of the device's design change and development process. The value of meeting minutes varies depending on where you are in the medical device development...