In my opinion, the first thought where the DHF is sealed and any updates after the design transfer are added to the DMR seems more logical. Technically, DHF is put together initially when the product was being planned, researched and…   Read more»

I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is classified as a Class III device in the US where as…   Read more»

Another difference between 510k and a technical file is the submission of a clinical evaluation report. All devices with a CE marking must have a clinical evaluation report. It is an essential requirement in Annex I of the Medical Device…   Read more»

One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be submitted regardless of where the medical device is being sold. The US FDA doesn’t…   Read more»

I used to work for an IT firm where I was assigned to a client that used to focus on VR for physical rehabilitation. Earlier, that company was hiring their own technology experts/consultants to provide the technology. Over the course,…   Read more»

I have not had an experience working with PMOA for a combination device yet. Upon some researching, I have found out that PMOA is very critical when establishing a product’s regulatory and product development framework. Technically speaking when we need…   Read more»

In my personal experience, I also had to sign a non-compete during on boarding which restricts me from working at certain companies. I have witnessed cases where my client wanted to hire an employee where we had a non-compete with….   Read more»

NDA usually excludes the information that is publicly available or information that was already made available to the recipient prior to its disclosure. It also excludes information which was obtained by a third party which may or may not be…   Read more»

Although, the team members enjoy working with people who they have a good rapport with. However, in my experience roles are allocated in a team based on a team member’s expertise and background. There are always few subject matter experts…   Read more»

I too have been a part of a Matrix organization. I would agree with the posts above that it does get confusing sometimes. I had a functional manager and a reporting manager for the same project. However, the things were…   Read more»

Delegation is one of the key differences between upper and middle management. Since a senior manager spends most of his energy on creating effective strategies. He has to be able to delegate decision making on non-strategic issues. In order for…   Read more»

Software can be an essential component of the medical device, whether it is designing a new product or improving the functionality of an existing one. When it comes to the software in medical devices, one seemingly minor change can have…   Read more»

There are several factors that must be considered when determining the appropriate sample size including risks associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing. It is very important to consider…   Read more»

Feedback plays a critical role in the design process. In order to make sure the review meetings go smoothly, the attitude of the team needs to be in order. The meetings should not devolve into firing lines where the team…   Read more»

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements….   Read more»

Adding to the previous posts, the format of the Design Verification is equally important. Although, format of the DV is not as important as the quality of information it contains. However, if the data does not flow correctly in the…   Read more»

Multiligamentous Ankle Supports (L1906) A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion. Medicare announced an additional verification for the ankle supports to 1. Include a…   Read more»

An important tip in creating a Gantt Chart is defining a critical path. It is a method of looking at all of the activities in the Gantt chart, considering the timing and dependent relationships of each, and calculating the longest…   Read more»

One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not be given access just to…   Read more»

Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs you define. FDA doesn’t really define User Needs in the 820.30 regulations per se. User Needs…   Read more»