The DHF and Technical file are different documents that have the same content. The Technical File is a snapshot in time of the design without giving much consideration to the design history or the mistakes that were corrected along the…   Read more»

Hi Andrew, I have always used Guidance documents to get better clarification on what the regulation is actually looking for. More specifically, I have used multiple MEDDEV guidance documents to make sure that I am following the right path when…   Read more»

Hi all, From my limited experience, it is indeed a lot easier to obtain EU approval prior to US approval. The main reason in my opinion is that in EU the manufacturer is not dealing directly with the regulatory agency….   Read more»

Hi All, I have to agree with most of you regarding 3D printed medical devices becoming a popular trend. I currently work in a pharmaceutical company handling design controls and Risk management activities for their combination products. I see that…   Read more»

From a legal standpoint, a written agreement is far more better than an oral one. As others have mentioned, a written agreement can be easily defended in court and can solve disputes quickly. with an Oral agreement, you get into…   Read more»

Hello Roberto, The gift restrictions are established by the Sunshine Act that came into effect in 2010. I had to personally abide by the restrictions of the Sunshine Act before. We were conducting a clinical study at one of the…   Read more»

As I have mentioned in a different post. I work in a hybrid organization that utilizes Functional and Matrix organization. This hybrid type uses project managers within departments. There is no specific team responsible for project management. Coming from a…   Read more»

I believe that all the responses above have mentioned what are the best practices to form a good project team. from my personal experience. Most of the time, you do not get the chance to pick your team members or…   Read more»

I believe that all the responses here are very valuable and they offer very good methodologies on how risks are identified. From my experience, Risk identification starts from the intended use, intended users and use environment. Once all these have…   Read more»

Good discussion so far everyone. As everyone have mentioned, Meeting minutes is considered to be a very important tool to track project progress and keep everyone on track. From my experience, if you conduct a lot of meetings (especially virtual…   Read more»

Design inputs do not only include physical and performance characteristics of the device. Design inputs should also include functional requirements, safety requirements, applicable regulatory requirements and -where applicable- information from previous similar designs. I have seen many companies struggle with…   Read more»

This is a very common question in the medical device industry. The best way to look at it is to understand the definition of both Verification and Validation. From 21 CFR 820: – Design validation means establishing by objective evidence…   Read more»