Hi All, As we all know, the US FDA handles Combination products according to their Primary Mode of Action (PMOA). For example, If the device PMOA is through chemical interaction, its approval process ...

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 s...

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 ...

As we all have learned from Dr. Simon's lecture this week. There are multiple types of clinical studies, including: 1- prospective 2- retrospective 3- Blinded 4- Randomized 5- placebo controlled 6- Mu...

As we all know, The definition of the Combination product is " a product comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a d...

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 activi...

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 ...

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 c...

Hello Everyone, we all learned this week about NDAs and CDAs. After working with consultants for about 3 years. I realized that some of them do not bind by the NDAs or the CDAs they sign. From my exp...

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 specif...

As we all have learned from this Week's videos, each organization structure has its own pros and cons. Each company is structured in a certain way to allow for full utilization of all available resour...

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 tea...

The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical...

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, intend...

As we all know, A major step of risk management is risk assessment and identification. Recently, usability has been a hot topic for risk management. Most Regulatory agencies around the world would as...