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 quality management systems, a complaint should be opened to handle an adverse event experienced by…   Read more»

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 precise dose consistently. The primary mode of action is from the drug. For…   Read more»

People in medical device regulations need to handle changes set by different regulatory bodies. Many companies also want to sell abroad or work with other vendors or sellers which have their requirements. Entropy is a natural occurrence in the medical…   Read more»

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 country from 1976 or prior are typically considered Class 1 and are likely to be…   Read more»

Medical containers and trays that are used to store surgical instruments benefit from stability testing. The regulatory requirements for these medical devices are less demanding than medical devices that are in direct contact with patients. Many of the container systems…   Read more»

Another aspect to consider when preventing adverse reactions is proper placement of the medical implant by the medical professional. Adequate medical training and manufacturer instructions are required for doctors in order to use the implant on a patient. Instructions can…   Read more»

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 knowledge on instrument chemistries and sterilization practices at the time. This meant using credible…   Read more»

Conducting preclinical studies is beneficial in risk identification and evaluation during project development. Many of the processes in industry need to be written procedures to prevent errors and increase data accuracy. Forms that are required for records need to be…   Read more»

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 stakeholder may be upper management, a vendor, or a customer. A successful project leader and…   Read more»

The planning phase of project management determines the required tasks in order typically using a work breakdown structure. Depending on the project, a lot of these tasks may be connected to each other and require specific charts or diagrams to…   Read more»

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 healthcare and medical device industries. Common challenges that AI can address include managing inventory,…   Read more»

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 industrial sector can be a highly rewarding and satisfying career path. I believe academia…   Read more»