As announced on Monday, October 17, 2016, by the United States Department of Justice (“DOJ”), the nation’s largest nursing home pharmacy, Omnicare Inc. (a CVS Health company), has agreed to pay $28.12...

NDAs offer a standout amongst the most surefire approaches to protect trade secrets and other private data intended to be kept under wraps. Data normally protected by NDAs may incorporate schematics f...

Dr Simon, I have learned a lot from this course. It gave me knowledge about the Regulatory affairs, Quality Control and Quality Assurance. It has helped me put the knowledge at work and I have been us...

I would prefer to have a matrix organization because : Assets are utilized effectively and can move around between projects as required. You can chip away at loads of various things, once in a while i...

Forming a project team is not an easy job. I would recommend to avoid following mistakes: Mistake #1: Not meeting with the whole team and setting goals upfront “It’s important for the entire team to k...

I would like to work for matrix organization because matrix management is ideal for sharing talents and skills across departmental boundaries. One of the most common scenarios for matrix management is...

Responding to the various categories of risk There are four basic responses available to businesses depending on the category a given risk is placed: Accept the risk as a cost of doing business, and d...

The best place to start is the traditional risk matrix. The underlying concept of ISO 14971:2007 is to estimate risk (the output of Risk Analysis in Clause 4), evaluate the estimate against the accept...

The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the a...

The Design Review process helps with other challenges of an engineering team like: Inter-org communication. Often people don’t know what other folks are working on. With very large teams you might eve...

bunch of tips and how-to tricks from several experienced project managers. Start date, end date, duration: Track it all The best way to track an ongoing project is using a Gantt chart. One important a...

Design inputs are the foundation of medical device development. And without a strong foundation, bringing a new product to market can be problematic. Call them what you want (design inputs, design req...

Five Tips for Passing Your FDA Audit with Confidence Passing a regulatory audit is the first priority of any manufacturer of medical devices. It can be an especially scary time for startup firms. All ...

Let’s dive deeper into why your design controls and risk management processes may be failing, and discuss what you can do about it. 1. Poorly Defined Product Development Processes — A medical device p...

HI All, While reading through the FDA Design Control Guidance pdf, I came across this section, Can someone answer the following two Q's? The quality system requirements for design output can be separ...