Hi All, Verification and validation of a process includes making sure that process and all aspects of it are meeting the correct specifications. As was stated above this would involve ensuring that e...

Hi All, I would say that the school of thought that appeals to me most is that the DHF is not a living document. As small processes change over time they can be inserted into the DMR, but not change ...

Hi All, I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It may be difficult for a small, US based company to ...

Hi All, After learning about Guidance Documents, I found them to be a very useful tool for getting devices approved in the EU. There are three groups that write guidance documents: MEDDEV Guidance Doc...

Hi All, I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification is purely based on a checklist and risk. This allows...

Hi Fady and Luisa, I would agree that it is a difficult measurement to simply say that every time a certain number. However I would agree with Luisa that a study needs to be clearly defined and there...

Hi All, One problem that I frequently face at my position is working out contracts for research. Each side typically has their own ideas and pieces that they would like included. As was mentioned, ma...

Hi All, I currently work in the pharmaceutical industry assisting pharmaceutical companies to outsource their pre-clinical research. I have also looked into medical device research outsourcing as wel...

Hi All, Thank you very much for the very interesting topic. I would agree that the restrictions in theory seem to be very strict. However I would agree with the level that they are set at. This is du...

Hi All, As the previous posted mentioned a written contract is greatly needed if any piece of the matter needs to be protected from a legal point of view. Oral contracts are extremely difficult to de...

Hi All, I believe that this was a very interesting course. As others previously mentioned, I believed that it would be a course that would involve more about theory of medical devices. I found this c...

Hi All, I would agree that all who posted that stated a Matrix organization would be ideal. This is due to the fact that a project based organization puts much responsibility on the project manager a...

Hi All, I would say that the best type of organization would depend on the specific company, but I would consider starting as a matrix organization. As a matrix organization, everyone would know each...

Hi All, Currently I work for a Matrix Organization. While I work currently as a Functional Manager because we are a start-up we work on many other side projects. This allows for many of the functiona...

Hi All, At my company we have a similar setup as was mentioned previously: 1- Documentation Reviews 2- Information Gathering Techniques like Brainstorming, Delphi Technique, Interviewing, Root cause ...