The guidelines consider risk to the patient in determining the level of medical decision making – risk of significant complications, morbidity and mortality – and they recognize three gauges of this risk: the presenting problems, any diagnostic procedures you choose…   Read more»

A Risk Management File (RMF) is the place where you keep your risk management activities, documentation, and records. It can be structured and organized by an individual product or for a product family. A Risk Management File contains evidence of,…   Read more»

Sole proprietorship is a type of business owned and run by ONE person. There is no distinction between the owner and the company. The owner is entitled to all the profit the company makes and is responsible for everything. Legally,…   Read more»

Public traded companies have a pro on, if successful, their financial growth year after year that provides momentum to their customer basis. On the other side of the coin, if a company is doing poorly, investors may become wary about…   Read more»

One aspect about this that I would factor in is that a private company can be tumultuous if the owners are thinking of selling their business. My one friend was working at a private company that was sold which led…   Read more»

@krp76 I would have to agree with you on that your first few jobs out of college should be focused on gaining experience. To be honest I never even considered looking into a company’s health prior to applying or accepting…   Read more»

A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk Management Plan. Hazard Analysis, Hazard Evaluation. “set of records and other documents that are produced by risk management”….   Read more»

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  I would say anything with pointy or sharp ends, electricity, or ventilators, etc. All…   Read more»

Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

While I do think the FDA is very strict, the drugs and devices that they are regulating affect millions of people. That being said, without regulations and strict rules, some of these devices could be harming more individuals then they…   Read more»

Posted by: @abhitrivedi1211 What factors contribute to determining values for risk index numbers. Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’. There are several factors that contribute to determining values for risk…   Read more»

Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  When dealing with risks, according to the FDA it is okay to use medical…   Read more»

Quality can seem as a burden or an annoyance because it is like a person constantly at your shoulder waiting to scold you or questioning your actions. IT may seem like a lot or overwhelming because a department may ask…   Read more»

Qa and QC departments are necessary to have for large companies. The purpose of a QA is that the provide a road map, a guide to how the company and projects will run. It creates a code of conduct, gives…   Read more»

In one of my projects, which was a biomaterial, it was similar to doing a mock product that could potentially go on the market. We had an issue with sterilization, although we had to meet a deadline, the only way…   Read more»

@zbw2 Certain regulations are in place to standardize practices among all medical device companies, not necessarily because these regulations will impact the effectivity of the product. For example, there are strict compendia regulations for how to test certain medical devices…   Read more»