I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of a process cannot be fully verified by subsequent inspection and test”. As…[Read more]

I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the user needs. When researching industry validation processes, I came across a New York Times…[Read more]

I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases especially with medical devices for validation to be done. Validation is key in determining and…[Read more]

I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so they have the ability to go public and spark some interest and attract investors (VCs, etc). The company should be incorporated in Delaware since they have more favorable corporate and tax laws. As @thu…[Read more]

I agree with @bb254 and @asimbana about the INC choice over LLC and would like to add more on the CONS. The biggest drawback is the double taxation (C Corp). Also, shareholders that control and own a significant amount, or majority, of the corporation’s voting stock have a dominant voice in the management of the business in comparison to s…[Read more]

I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower risk. For example in 2010 Johnson and Johnson underwent a quality control reorganization after both the House…[Read more]

I agree with @asimbana, both departments have different objectives, which is why you’d find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be conflicting when it comes to the actual production and finalizing of products. These are the types of situations that should…[Read more]