There is a huge difference between an NDA and a patent. The patent is a federal document utilized to protect and enforce the exclusivity of an idea. An NDA is a contract between two people or a person and an…   Read more»

I don’t think you have to go too deep into kickback allegations to find some really high profile cases. Take this case with Senator Robert Menendez and his Floridian eye doctor associate. http://www.businessinsider.com/bob-menendez-defense-fund-took-money-from-developer-jailed-for-kickbacks-2015-4 Where Senator Menendez was indicted on 14…   Read…[Read more]

There is an old adage that a wise engineer once told me; Always, always get everything in writing. Getting things in writing would make everyone’s life easier… But only if the person who prepared that document is ready to devote…   Read more»

I also agree with this. The way managers and directors express their direction promotes the team building within the department. I have experienced both sides of the coin and like you I do prefer the welcoming work culture. Even though…   Read more»

I believe that it is much better to work with someone who is knowledgeable and would occasionally give you a tough time than with people who you are highly comfortable with. This way, any potential hurdles/conflicts are handled professionally making…   Read more»

I highly agree with this sentiment. Corporate culture can change in the blink of an eye. I too share the same experience where shuffling management has resulted in a drastic change of perceived job security and camaraderie. However, the amount…   Read more»

Usually the quality management system establishes the guidelines to periodically perform a risk assessment. This risk assessment is performed by people who are qualified to perform such activities; an engineer familiar with the device, a quality representative that performs CAPAs…   Read more»

This is a great discussion topic! I believe many of the failures in risk assessment can come from a lack of resources within the company. By resources I mean information and or the personnel required to adequately provide an honest…   Read more»

As already discussed by others, the best ways are a quality system supported DFMEA matrix, collecting information from various sources such as the complaints department and the past quarter’s CAPAs and NCRs, SWOT analysis and others. I believe the best…   Read more»

I believe that Gantt charts are great to keep you in focus with what your deliverables, milestones and project scope should be. In my industry experience, I’ve used Gantt charts to address CAPAs and NCRs. The CAPAs would require a…   Read more»

Roberto this is an excellent topic of discussion and as you will find in the field, often a topic of contention. The FDA provides guidelines on how tests should be executed. Take a look at the recent changes to the…   Read more»

Even though the lecture cited examples, I would sleep easier knowing validations were done to mitigate risk. Even if there were no changes affecting the human factors of the device, you still need to check the product. What if there…   Read more»

Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized…   Read more»

Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device…   Read more»

Lamiaa: Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working…   Read more»