The type of clinical trial my group is involved with is a prospective clinical study which is collecting data in real time. We are 20 locations that enroll at least 10 qualified patients into the trail with a max of…   Read more»

I’m not positive why a clinical trial would be shut down, but if I had to guess I’m sure it would be due to some unethical situation or if someone broke the guidelines set at the beginning of the trail….   Read more»

In the current company I work for, I could potentially see myself working in Clinical Development (basically the same as clinical research). I would be able to screen the patients for the trails, create the protocol needed for the trials…   Read more»

Since the quality department can’t perform their own audits and internal audits are necessary for companies to find and mediate risks in their quality system before an FDA audit happens. Most companies hire an outside person to complete an internal…   Read more»

Good manufacturing practices (GPM) are quality regulations that medical/pharmaceutical companies follow in order to reduce the risk when producing medical devices. The company I currently work for has not updated there GMP guidelines in the last 6 years, but when…   Read more»

Pros of internal audit: 1. Improve efficiency in operations 2. Ensure compliance with laws and statutory regulations 3. Risk assessment 4. Provides observations and recommendations to improve processes and controls 5. Identifying gaps, also known as “trouble spots,” where procedures…   Read more»

While I do not have experience as a project manager I do believe that all roles are equally as important, but if I had to pick one in which I believe the project manager had to be the most fluent…   Read more»

My company is all about funding the R&D department and pushing for innovation but while they are willing to fund the R&D department in completing their research they are not good at funding to hire more staff to help work…   Read more»

I believe the companies main priority is to produce a device that will help the company profit, and we know that this isn’t always the case. If a company has already started funding a project and has invested x amount…   Read more»

Technical writing is extremely important in industry, but unfortunately, during my time as an undergrad at NJIT, I was not exposed to any technical writing classes. Luckily within my first month working as an R&D engineer intern a Technical Writing…   Read more»

The quality of your writing style should create a similar impression on the quality of the work being performed. When writing or re-writing an SOP you should include only details that clearly and concisely get the message of the task…   Read more»

ECO’s (Engineering Change Orders) are used for changes in components, assemblies, or documents such as processes and work instructions. I have not filed an ECO at work but one of the Sr.Engineers on the team did go through an engineering…   Read more»

Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. I do believe that an SOP should be created for any testing created/done in the research phase because it…   Read more»

I believe the design history file (DHF) is more useful because it is a compilation of documentation that describes the design history of the medical device and gives a better history outline of what the medical device has gone through…   Read more»

I believe that deciding between a re-executing full verification and validation protocols or conducting a regression test depends on the situation. In my company there base all decision on the severity of the situation and risk factor. This past week…   Read more»

A design history file (DHF) is a compilation of documentation that describes the design history of a finished medical device. In my option, The DHF is a living document, which means as changes are made to the medical device, SOPs,…   Read more»

Medical Device: Mitral Clip Definition: Mitral Clip is used to is reduce mitral regurgitation (MR ≥ 3+) due to a primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for…   Read more»

Clinical data required for premarket approval is a significant difference in time-to-market approval in EU and US. Medical devices in the EU is regulated by three directives. The main directive being Medical Devices Directive (MDD). These three directives have been…   Read more»

I have no experiencing dealing with legal contracts but at Edwards, there is someone from every department assigned to a project; quality, manufacturing, clinical, pre-clinical, technicians, quality, regulatory, marketing, all levels of management (typically below the V.P.), R&D engineers, Test…   Read more»

Multi-center clinical trials are the type of clinical trial that my team at work is trying to get approval for. From my understanding there is no “good number” but rather we want as many sites and as many people in…   Read more»