Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at all cost. One deviation I…   Read more»

Scheduling time for each person to complete assignments is definitely a bottleneck or can become one. One way to get around this is to schedule around the persons personal time off and have them approve of it. Another potential setback…   Read more»

When I attended my first design review meeting, I did not participate much because my project lead and supervisor led most of the discussion. However, I had my validations and other documents prepared in case I was questioned on process…   Read more»

On a daily basis, I almost always refer to the project plan (gaant chart) to give me guidance regarding the project deadlines and other assignments. This is particularly useful because I see what my action items are and what steps…   Read more»

Design review meetings at our company are very big in the sense that various members of several departments are invited. There, the project lead discusses the progress and changes in the device and asks for recommendations or is given feedback…   Read more»

At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the engineer creates a change notice which contains…   Read more»

Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed in a meeting or in a brief conversation. Then the person who becomes responsible for making the changes…   Read more»

One of the tests I have seen done to check the integrity of the package is known as the burst test. Basically, it works just like it sounds. The package is connected to a machine that increases the internal pressure…   Read more»

I believe that the company needs to decide using a risk-based approach. The medical device industry is governed by risk and because of that each decision made should account for potential setbacks that may arise. If the project is a…   Read more»

I agree with puneet as that there aren’t many risks involved in performing v&v testing. The risks come into play if the requirements/specifications cannot be verified or need to be changed. If so, a design change review meeting may need…   Read more»

Requirements for a project proposal are as follows: A description of the product along with its intended use and targeted customers. The market size and selling price should be included. There should be a section that discusses the products specifications…   Read more»

The quality plan or quality manual of a company shows the commitments of the company to quality and compliance. Upper management has executive responsibility. Some companies adopt clauses written within ISO13485:2016 to show compliance. The Quality Plan is designed to…   Read more»

In my current position, my team and I focus on Design Verification that is within Design Controls. Design Controls is an extremely important guide to engineers within the Medical Device industry. I believe that all of the steps of the…   Read more»

Since the FDA sees the Fitbit as a nonregulated device then it will stay as such. If the FDA considered the Fitbit as a medical device then regulations would need to be in place. Given that the device is a…   Read more»

Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in the medical device industry are essential and necessary…   Read more»

Verification and Validation should be done in accordance with Design Controls to ensure proper alignment with correct processes. Verification should be completed after outputs of a design have been established. Then as the device is being reviewed, validation should be…   Read more»

As as934 stated, it depends on the business. Upper management decides what the company should focus on given prior experience, etc. Low-priority projects are often put on the back burner because of that main reason – they are not important…   Read more»

There are other engineering programs that better prepare the student for the given coursework, however, students should also take the initiative to work on their interpersonal skills. Given the nature of the business, students should still invest in school mainly…   Read more»

I believe that this isn’t restricted since bribery isn’t and shouldn’t be taken lightly. As stated in lecture, doctors would receive expensive packages and deals from company employees just so that their products can be favored over others regardless of…   Read more»

Before discussing whether if an NDA acts as a substitute for a patent, it is worth mentioning the differences between the two. A patent is essentially a given right to the inventor saying that he/she or a group of people…   Read more»