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 $28.125 million to resolve allegations that it solicited and…   Read more»

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 for another item, customer data, deals and promoting plans,…   Read more»

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 using your presentations to…   Read more»

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 in parallel—despite the fact that…   Read more»

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 know roles and responsibilities and…   Read more»

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 when a group of individuals from all different functions…   Read more»

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 decide to retain and budget for…   Read more»

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 acceptability criteria (in Clause 5), and determine…   Read more»

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 availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may…   Read more»

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 even have two different engineers working on the same…   Read more»

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 advantage of these charts is that…   Read more»

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 requirements, design and development inputs, etc.), getting your design…   Read more»

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 three medical device startups agree that…   Read more»

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 product development process needs to establish the…   Read more»

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 separated into two elements: Design output should be…   Read more»

Double blind procedure is a method of enhancing internal validity in an experiment. In double blind procedure, neither the researcher nor the subjects are made aware of which group is the experimental group and which the control group. In double…   Read more»

I would like to Sponsor a clinical research. The reasons are as follows: 1. Selecting a clinical investigator 2. Monitoring the research 3. Ensuring clinical trial is being conducted as per the protocol and regulations 4. Making sure that investigators…   Read more»

Hi All, Please read below the pros and cons of clinical studies. Pros 1. You may get promising new treatment methods that you can’t get outside clinical research. 2. The new method may have less side effects than the usual…   Read more»

4 STEPS TO A SUCESSFUL PRODUCT LAUNCH The top four challenges faced by a new medical device product launch team are planning, communications, implementation, and follow-up. To achieve a successful medical device launch, all disciplines involved with the new device…   Read more»

https: // http://www.mindtools.com/ pages/ article/ newCDV_59.htm