My previous response was intended for your other discussion on public versus private companies, which I added there. However, I want to add to this discussion about cash flow versus profit. Understand...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

Evaluating financial ratios can determine if a company is capable of investing for returns that come later. A balance between short term financial goals versus long term investment can depend on the p...

Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided examples of frequent problems that can arise. As a result...

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 revising sections that need to be improved on so that the...

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 opene...

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 ac...

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 requireme...

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 Clas...

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 t...

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 require...

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...

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 inc...