It seems like one of the simplest and most cost effective ways to conduct post-market surveillance would be to request feedback from the patients using the device. For example, if the device is a knee replacement, it would be in the best interest of the company to request the feedback of the doctor/surgeon applying the device for any issues that…[Read more]

Great question, Luisa.

From previous experience, I, myself, have been responsible while working in the research phase to create SOP’s. This is important even for research and development because SOP’s are needed for operating small scale equipment and testing equipment, even at the research stages. I would often create SOP’s for small scale…[Read more]

Great question, Chris. I had a similar problem at a previous job when I was responsible for writing and updating SOP’s as well.
One problem that I often came across was including troubleshooting instructions in an SOP. As I am sure you can imagine, describing common errors and sounds that can occur while operating was not easy and including i…[Read more]

I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts. For example if you wanted to qualify a production line of some tablets in a bottle, all of the steps between would need to be qualified first such as: the bottle cleaner, bottle filler, tablet…[Read more]

I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&D area. When needed for production, it would be used there and when it was not in use or scheduled for use, it would be used in the R&D area. This was done for two reasons: to save money (equipment…[Read more]

Syringe Filling Process
IQ- Filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it
OQ- Syringes are filled with bone void filler to the same level and amount within a range each time (either checked by weight, or if density varies, by volume); Fil…[Read more]

From my experience, your product will almost always require both a DHR and a DHF. The reason being is that one is for the design phase (DHF) and one is for the production phase (DHR). A DHR shows how to produce the device to meet the specification (drawn up by the company.) A DHF ensures that during development, the proper protocol was followed…[Read more]

From my experience, the most post-market surveillance we would receive is from the end user, or the patient. People will often call the company’s main hotline if they have any major complaints. Additionally, doctors, responsible for administering the device, also were quick to provide feedback on any faulty designs. In some cases, patient s…[Read more]

Verification is making sure that the product/ device is functional and performs as it should. It entails testing, inspections, and analysis. Validation is making sure that the product/device is useful and meets the needs of a consumer. It ensures that the product or device has a market and a purpose for existing.

V&V overlap for both the device…[Read more]

In my opinion, the tech file/dossier is more useful. The reason being is that it gives an overview to the entire product and design and is most useful to someone that was not heavily involved in the device’s development. This is most useful when device failures come to light for someone that was not directly involved in the project but is r…[Read more]

I think that the DHF should be a live document. The reason being that from experience, the original idea of the device is rarely ever the outcome. While it may be useful to have a document of the thought process, it is more useful to have a record of what the device ultimately became, on the production line. The document would most likely be more…[Read more]

I would tend to say that device approval is easier in the EU because it is faster. And it is faster because it is simpler and is based on a checklist that leaves little room for gray area and saves time by eliminating the need for further discussion. Furthermore, the EU requires that clinical safety be proven (for Class IIa, IIb, & III devices)…[Read more]

I would say that NB-MED guidance documents are the most useful to follow. The notified bodies have the power to inspect devices and can lead to a suspension or halted sale of the product. This can cost a company a great deal of money, not only modifying the product to make it up to standard, but also in loss of time, product, and manufacturing. To…[Read more]

Great question, Fady!
I have some experience with filing combination drug product in the EU. One instance, in particular, that comes to mind is a topical gel for scarring that was accompanied by a massaging applicator. The purpose of the applicator was to penetrate the scar tissue with the gel in order to achieve the greatest effect to minimize…[Read more]

Hello Fady,

I have a small amount of experience in working with PMOA’s for combination products. In my experience, I have worked with drug/device PMOA’s and the separation of two drugs until consumer use (for example: two active vitamins are separated until the granulate is poured from the package, which contains 2, independent cha…[Read more]

Hello,

Previously, I worked in the OTC pharmaceutical field but since becoming a full time graduate student, I have a stemmed interest in medical devices for women’s health and have recently become involved in a project focusing on intrauterine devices (IUD’s). IUD’s were not popularized until the early 2000’s and have continued to rise in popu…[Read more]

Hello Andrew

When I worked in industry and had trouble getting contracts signed and have input on everything, I would often request a meeting. It usually wasn’t in person, and that wasn’t necessary anyway. Typically, I would gather a lawyer from my group, my manager (if they were available- optional attendance), and the representative the…[Read more]

Hello Andrew

When I worked in industry and had trouble getting contracts signed and have input on everything, I would often request a meeting. It usually wasn’t in person, and that wasn’t necessary anyway. Typically, I would gather a lawyer from my group, my manager (if they were available- optional attendance), and the representative the…[Read more]