Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew that in order to get…   Read more»

As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn the standards of…   Read more»

While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up creating a lot more work in the long run. Just…   Read more»

SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and attachment sections. All SOPs should be written in a concise…   Read more»

SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every fixture or process that is in place. It is not just focused…   Read more»

The current company that I work for uses ECOs in the form of change notices as Julienne has stated above. The process of implementing a change within an SOP requires engineering to supply a redline and final draft of the…   Read more»

One advice that my manager told me when dealing with a complete rewrite of an SOP or creating and SOP is to make it “idiot proof”. This terminology is used to make it clear that whatever is being stated in…   Read more»

The company I work for does utilize a Design Specification document as Dr. Simon had described in this week’s lecture. It includes a design matrix that traces the entire process of the design. It is a living documents therefore it…   Read more»

From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification. Yes, this is time consuming and can be costly, but it is the cleanest way to reroute the protocols….   Read more»

Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes or scrapped information that were made along the process of designing the device. A Tech…   Read more»

Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives but does not state how to enforce the law….   Read more»

I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning about it the pacemaker. A pacemaker is considered in the…   Read more»

Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA makes the sole decision on if the medical device meets the regulations. EU regulatory is…   Read more»

One of the major marketing strategies used within the company I work at is the fifth P. Our products are mostly used by surgeons and physicians; therefore, the marketing group will hold meetings with hospitals to discuss the product. The…   Read more»

Personally, I have not experienced working out a legal contract at work first hand. However, I was informed that our company had a major fall through with a legal contract with a warehouse that distributes our main products. The timeframe…   Read more»

Two years ago, I was working in a human performance lab that was gathering data on neuromuscular activity from patients after chemo treatments. The focus of the research was to see how chemotherapy from breast cancer survivors has affected neuromuscular…   Read more»

I never directly dealt with a non-compete agreement but my brother in law has. He signed the agreement two years ago and found out recently the consequences of it. When he decided to defer his contract, he was obligated to…   Read more»

Verbal agreements much be accepted by the law, but I was always taught that “if you don’t have it in writing then it doesn’t mean anything.” This saying comes into use whenever I work on a project. Whenever I have…   Read more»

This course was very beneficial in learning about the different design controls, business and regulatory aspects of the medical device industry. I previously took your project management course and preferred that structure of the course over the medical device course….   Read more»

Based on my experience, a functional organization seems to work well in large companies. Yes, a disadvantage is the creation of silos but that can always be resolved. Having an IT, marketing, finance, quality, manufacturing departments allows the members of…   Read more»