To add to other posts on this forum, another factor to consider during benefit-risk analysis is patient perspectives. If the risks are identifiable and definable, risk tolerance will vary among patien...

Just to clarify, the term audit is used when an internal company department performs evaluation of the company procedures, processes, facilities, etc. whereas inspection is when a regulatory agency vi...

Appropriate procedures for design controls is a critical requirement of 21 CFR 820.30 to ensure the product development follows a systematic approach while documenting the decisions made along the way...

Design validation ensures that the device conforms to defined user needs and intended use(s). While some design validation can be done through "bench testing" most likely if the device requires user i...

Risk analysis is part of Design Control System and one of the aspects regulatory agencies look for is the integration of risk management to complaint handling. Establishing a risk management file is c...

While I understand the importance of Henrietta's harvested cells brought to advancement of research and benefits to society, I believe her cells were taken without her consent. Her rights were violate...

If I was involved in a clinical trial I would like to support the study as clinical investigator. As others fellow students alluded to the clinical investigator's primary responsibility is to ensure t...

Clinical background is not required for all functional roles in a clinical study as stated by many in previous posts, although I think it is critical to have experts with clinical background in the st...

One approach currently used by medical device companies is to showcase their products during medical device conferences/ summits/ expos that are attended by physicians, other technology companies, pat...

A medical device company of mid-size with 50 people and $10 million in revenue should exist as "Inc." as opposed to "LLC". As stated previously by others in the forum, there is a drawback of double ta...

The legal structure is one of the most important decisions in the start up process. The choice will depend on the best advantages that a structure provides based on the company needs, risks, and abili...

I did some research on Medtronic, these are my findings: Gross Profit Margin = indicates the percentage of revenue available to cover operating and other expenditures: 0.6873 (2017), 0.6829 (2016), 0....

I believe that conflicts between R&D and Quality departments can be significantly reduced if both functions understand their role. For example, the R&D department considers itself responsible ...

One of the issues that I experienced is how the quality organization of a company was structured. There was a quality department designated to support development (R&D) products and another qualit...

The complain that Quality is a burden must come from people that do not understand the history of manufacturing mistakes that resulted in products that put people's lives at risk and intricacy process...