As stated in the question: verification is required to ensure that the product works and that it is safe for a patient to use.  An example of this would be bandaids. I think, when designing a bandaid, it would be…   Read more»

Verification protocol is very essential to demonstrate the safety of the device on the user. an example would of a product that needs verification protocol before it is allowed for the public to use be the covid 19 vaccines. this…   Read more»

Abbott Cell-Dyn (CBC instruments) verification protocol should have to test the amount of blood the syringe take in from the tube in both open and closed mode, the time it take to give the results, the shear valve segmentation of…   Read more»

I did a search about Jordan regulation and i really found it interesting. As it is a small country, i did not found anything about development of medical devices, but all the regulation are based on device coming from other…   Read more»

I have very little experience on this topic, therefore it was very good and informative to read your comments and experiences designing statistical parameters for testing controls. The only experience related to this that I have is meeting manufacturer standards…   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»

All the 9 are very important, but you can still find projects done without some of them. – Planning should have breakdown of tasks alongside the people/team responsible for them, a Gantt chart is the best example for it. -…   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»

An example I can think that would require many different validation processes in order verify that it is doing what its supposed to is an artificial heart valve. The valve must have been tested in the laboratory to mimic its…   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»

This is a very interesting post since I do not have much experience with this topic. I have been involved in validations and the development of laboratories by acquired CLIA and others, but have not had the chance to work…   Read more»

The DID and DSD tie in very nicely when developing Verification and Validation procedures. The Design Input Document should be used for Validation, where the resultant function of the product is assured to meet consumer needs. The Design Specification Document…   Read more»

Outsourcing manufacturing is often cost-effective for companies. Cheaper materials and optimized manufacturing processes can lead to cheaper products and faster production. However, outsourcing can also lead to sub-optimal quality inspection. Outsourcing manufacturing will require a more extensive Design Transfer Process….   Read more»

One of the most important factors of the engineering design process is ” If it is not documented, then it never happened”. This applies to meetings too. Someone should be keeping track of the meeting conversation in some sort of…   Read more»

I think any ethical issues related to the Right to Try Act can be mitigated by clear communication between the physicians and the patients. The RTA specifies that the patient must be diagnosed with a terminal illness. I think participation…   Read more»

Posted by: @amd29 No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing. I think this statement is just false. I guess…   Read more»

I disagree with your statement that “placebo treatment is better than no treatment at all”. In fact, I think that is the biggest ethical dilemma in utilizing PCTs. Medical professionals have the responsibility to provide optimal medical care to the…   Read more»

I agree with everyone that keeping meeting minutes is super important. It gives you something to reference in the event that you missed something in your personal notes. I know personally looking back at meeting minutes has been helpful in…   Read more»