A patent gives the company legal ownership of an idea or design. This allows for the owner of the patent to have exclusive ownership of the idea or design, and gives them the right to sue for patent i...

While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in regulatory complian...

I have had two jobs where a non-compete clause in my employment agreement. The first one had clause where I could not work for a competitor within a certain distance from where I was working for six m...

When forming a project team, I think it would be best to be able to assemble a team of people who have worked together before and have shown to be able to work well together. However, in many cases th...

In my opinion, I think that matrix organizations are the most effective types of organizations. Since employees are still part of a functional department, it can be easier for them to align on certain...

The organization that I work for would be considered a matrix organization. People are organized by department, and project teams are creating by taking one person from each department. This is useful...

Post-market surveillance is now required by the FDA. Med device companies must have tracking systems in place, report medical device malfunctions, injuries and deaths, and register where the devices a...

In agreement with some of the replies above, some residual risk is acceptable if it is necessary for the function of the device. In these cases, it is important to consider who will be using the devic...

In my experience, FMEA has been the most beneficial tool to use for risk management. Every product in my company has a D(esign)FMEA and a P(rocess)FMEA associated with it to document which failure mod...

Tests used for design verification must be able to demonstrate that a particular characteristic of the medical device is conforming to the specification. As mentioned in other responses, the FDA does ...

Design Verification testing for any medical device will demonstrate that the product meets all of the specifications listed out in the DSD/Product Specification document. For a balloon catheter, some ...

In my experience there are three parts to process validation: the Installation Qualification (IQ), an Operation Qualification (OQ), and a Process Qualification (PQ). The purpose of the IQ is to ensure...

In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the meeting will send out an agenda with the meeting in...

As an R&D Engineer, I work with a lot of the types of documents that were described in this weeks lecture. For our Design Input Document (DID) we have a document called a Market Specification, whi...

When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is often called a Root Cause Analysis. In a root cau...