Hi All,

My best understanding is that the Design History File (DHF) contains all information about the development of the the product, as the design is created. It contains all inputs, outputs, and protocols. The Device History Record (DHR) is contains everything that was done to manufacture the device. This includes, when it was manufactured,…[Read more]

Hi All,

Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical device, like device failure. There are even requirements for some Class II and III medical devices to have required post market surveillance.

The main way that post-market surveillance can be…[Read more]

Hi All,

Thank you very much for this interesting topic. I have not worked too much with ECOs; however I do have a bit of experience. I have needed an ECO in the past for a change of an SOP. In most cases I have worked with it was a change in a SOP, where a newer procedure was created or a new technology was created or better utilized that needed…[Read more]

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 equipment used during testing is giving accurate results. This equipment, after being verified, would then be used to run the verification test for…[Read more]

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 the nature of the device. I believe this because a device is designed with a specific purpose and use; however if that use changes a new DHF should…[Read more]

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 have an authorized representative. Small companies may not be able to afford or obtain an Authorized Representative in the EU. Even though there are…[Read more]

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 a device to be designed and the company to know exactly how the device will be classified and they can simply follow those regulations. In the USA,…[Read more]

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 needs to be enough patients in each center. I believe that one of the most important things is ensuring that there is enough patients at each…[Read more]

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 well. One of the main trends I can see is the outsourcing pre-clinical research to more diverse suppliers. From what I have seen most pharma and…[Read more]

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 due to the fact that bribery can take many forms and can greatly influence people. Thus, having these restrictions avoids situations that can…[Read more]

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 defend in court as it is difficult to show all the aspects of a legal contract; such as offer&acceptance, consideration, and full capacity of the…[Read more]

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 course very useful, as I have been working in the drug development industry. Although the process is somewhat different, it was very useful in…[Read more]

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 and their team. In an ideal world where all members worked well, this would not be an issue. However because the project teams would work…[Read more]

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 other, and knowledge would transfer well. All these characteristics are needed in a startup. A startup needs not only good management of resources…[Read more]

Hi All,

I would say that the best type of organization would depend on the specific company I would consider starting as a matrix organization. As a matrix organization, everyone would know each other, and knowledge would transfer well. All these characteristics are needed in a startup. A startup needs not only good management of resources and…[Read more]

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 functional managers to become project managers for projects that we are conducting rather than our normal workload. I very much enjoy this type of…[Read more]

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 analysis
3- Checklist analysis – previous similar project, lowest level RBS
4- SWOT Analysis
5- Expert Judgment.

However after a SWOT analysis is d…[Read more]