since already many have talk about some of the examples, there are some benefits of ECO. following good ECO practices it will make thing easier when documenting a full history of what change have been made to a product and when they occurred. In industries with regulatory requirements, like the medical device industry, having a full history of…[Read more]

since everyone have mention about why SOP should be required during research phase, i want to add some information about SOP. SOPs should be reviewed by appropriate individuals. Reviewers could include colleagues who will be using the SOP, Quality Assurance (“QA”) managers, research facilitators, lab manager(s) or governance managers. A rev…[Read more]

yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:
-the design, production, labeling, promotion,…[Read more]

i dont have experience with this, and since a lot of student have answer i want to add some information about the Authorisation procedure. it said that the Full copies of the marketing authorisation application file are sent to a rapporteur and a co-rapporteur designated by the competent EMA scientific committee. They co-ordinate the EMA’s…[Read more]

The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Administration. According to a survey funded by the Institute for Health Technology Studies, medical device companies (263 out of 350 or 75%) are pursuing…[Read more]

It seem that a lot of people here had agree with me that Clinical research wouldn’t take this career path, one thing that I do like was that CRA can travel for free and work for home that’s one of the good benefit but like jnm22 friend, after a period of time she got tired of traveling this seem for a person that lived alone, and don’t have to wo…[Read more]

Very good question, this simulation have help me understand how actually, some of the stuff I would be dealing in the industry and how I have be knowledge about many factors. All the simulation were very interesting, each dealing differently which help us understand different aspects. I haven’t been in the industry but with this simulation now I h…[Read more]

Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention, depending of the used of the device the risk could change. In addition to this, it got me thinking about combination of product. There are different type of combination product, Drug, biologic,…[Read more]