Sunshine laws are regulations created to deal with these kinds of conflicts. In most basic, it requires business in multiple different industries and businesses, such as the health industry, to make their certain operations transparent and available to the public….   Read more»

Personally, I have never been offered such an agreement, but I do know of them. In most basic terms, these agreements are to fire employees without any legal issues. Most companies have huge legal departments who professionalize in these contracts…   Read more»

The best advice would be to READ AND UNDERSTAND the document FULLY. Furthermore, the language must be precise and to the point so that no secondary meaning could be understated. Any secondary or hidden meaning can penetrate the legal protection…   Read more»

NDA or Non-Disclosure Agreement is simply a contract. If that contract is violated in any way, there is a chance to sue the one who violated the contract. They are not bulletproof, but they can offer some protection against some…   Read more»

Posted by: @dbonanno1 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you…   Read more»

Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

There are a lot of consultants in the medical device industry. N most basic, they all have a deep understanding of ISO9001 and ISO 13485. Not every medical device consultant can work with every device, though. They usually specialize in…   Read more»

Posted by: @jp582 As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially utilized for failure and…   Read more»

Dealing with risk, there are certain steps to follow. To start with, a risk register must be created. A risk register is basically a spreadsheet that includes areas to put information about the description of the risks, the likelihood of…   Read more»

Posted by: @dyc6 Another factor contributing to risk values is the percentage of false-positives or false negatives, particularly for diagnostic devices. For example, if a patient is scanned (with X-ray, MRI, ultrasound, etc.) and the result is actually a false…   Read more»

To start with, DDP stands for design and development plans. DDP aims to describe the product or design to create a chart of its production cycle, marketing, and company procedures and regulations. In my view, a person who needs to…   Read more»

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

Posted by: @savery115 Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past – how have you explained or ensured that the sampling plan and statistical approach you…   Read more»

There are various things that the FDA will be looking for in a Design Contol System. (1)Design and development planning. (2)Design input: It has information about the intended use and sure needs. (3)Design output: It tells if the output meets…   Read more»

The design control process in Turkey is done by the Turkish Medicines and Medical Devices Agency. It follows ISO 13485 and ISO 9001. For Turkey, medical devices must have CE markings and must be registered in the Turkish Ministry’s Online…   Read more»

There are many constraints in the development of medical products and devices. Identification of these constraints is important, and there is a procedure to follow named design controls. For medical devices, design control is needed from the Food and Drug…   Read more»

Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are…   Read more»

Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

Posted by: @sam-doksh Clinical research is a is the study of health , it is important for the progress of modern medicine. It determine the safety and efficacy of medications, devices, and treatment regimens intended for human use.    …   Read more»

When I first read the title ”Sales vs. project management”, it didn’t make any sense to me, but as I thought about it, although it may not be obvious, project management is crucial for effective sales. The consumer themselves have…   Read more»