Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most of you seem to prefer a Matrix structure. In my opinion a Matrix structure is great but it puts a lot more pressure on the staff. As discussed you have two bosses. This type of architect can be h…[Read more]

Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly relay the information required so that the intended user applies the device in its intended use. Now of course you can’t train physically everyone but that is why the videos are available. The v…[Read more]

I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our products. A combined view of all these quality system documents really help most engineers wrap…[Read more]

In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation there are several methods one can use to get to the root cause of the problem. This can include several different…[Read more]

The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and displaying the critical path of a project, however, they have their differences. In the simplest form A Gantt chart is basically a bar chart and a PERT chart is a flow chart. The Gantt allows you to view…[Read more]

I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this is not always the case. At the company I am currently at we have something called out in our design review SOP called an abbreviated design review. This type of review is usually only one or two mee…[Read more]

Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what was discussed and reviewed during that meeting. In most companies there will be an SOP for all general Meeting Minutes (which will usually include: general instruction and a boiler plate template for…[Read more]

Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yourself “Did I make this product correctly”. This means you are matching if the product meets the requirements and specifications and functions as necessary. Whereas in the validation process you are…[Read more]

Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed safe and effective. Design controls are documented, objective evidence you establish throughout the product development process to prove your device is safe and effective. There is almost no way to…[Read more]

“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union) under the Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and for CE-Marking, r…[Read more]