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 t...

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 dep...

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 hidde...

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 ...

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 ...

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 ...

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...

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). FMEC...

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 descri...

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-...

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 ...

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. Bef...

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 t...

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)D...

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 regis...