I would enhance what is already in place rather than initiating a system that would take more time. A thorough review of the QMS would include revisin...

QA should conduct an investigation if an adverse event occurs or if post surveillance data detects an issue with the medical device. As per most quali...

Nasal spray is a combination product because a drug is prepackaged in a delivery system that enters the nose. The pump can be specialized to deliver a...

People in medical device regulations need to handle changes set by different regulatory bodies. Many companies also want to sell abroad or work with o...

In terms of general reform or changes, what came to mind was the Medical Device Amendments of 1976. Similar medical devices already sold in the countr...

Medical containers and trays that are used to store surgical instruments benefit from stability testing. The regulatory requirements for these medical...

Another aspect to consider when preventing adverse reactions is proper placement of the medical implant by the medical professional. Adequate medical ...

I have some industry experience in a small laboratory setting. What I did to expedite the progress was online research because I did not have much kno...

Conducting preclinical studies is beneficial in risk identification and evaluation during project development. Many of the processes in industry need ...

This post highlights the significance of project roles, especially the project leader or manager role. A project leader may also be a stakeholder, or ...

The planning phase of project management determines the required tasks in order typically using a work breakdown structure. Depending on the project, ...

AI can be a useful tool in the medical device industry if used appropriately. I hope that AI can continue to drive sustainability efforts in the healt...

I prefer the industry sector of biomedical devices because that is where my experience is. Depending on the nature of the person, the academic or the ...