As we all have learned this week from Dr. Simon, If any of the Verification or Validation test cases have failed during the V&V processes, the specifications have to be either reviewed or changed and these tests have to be repeated. From my experience, sometimes a regression test is sufficient to test the changed specifications. In other cases,…[Read more]

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 is handled through Center of Drug Evaluation and Research (CDER). In EU, the term combination product does not exist. Products are either considered…[Read more]

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- Multi-Center

There are many advantages of doing a clinical study with any of the methods mentioned above. The multi-center clinical studies looks like…[Read more]

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 drug, a device, and a biological product. Under § 3.2(e), a combination product
includes:
1. A product comprised of two or more regulated components,…[Read more]

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 experience, We hired a consultant who was helping my company establish design controls for our company. After working with the consultant we found that…[Read more]

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 resources. I have worked in different companies that utilize different organizational structures. I have worked in a small company where organization…[Read more]

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 device manufacturers. It is a gray area where lots of questions float around. The regulation is clear. it states As Far As Possible(AFAP). What is…[Read more]

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 ask for the company strategy to mitigate risks arising from use issues. Some manufacturers utilize and Application FMECA to address use issues. Other…[Read more]

Combination products have been controversial topic since the introduction of 21 CFR part 4 in 2013. Combination products can consist of Drug & Device, Biologic & Device, or drug/Biologic. Most Drug and Biologic products requires Clinical trials that are divided into phase I, Phase IIa, Phase IIb and Phase III. During phase I clinical studies, the…[Read more]

As we all have learned this week, a validation may not be required if:
– There were no changes required to the product after verification.
– A clinical trial is not required
– Product changes did not affect the user interface

From my experience, the human factors study is considered a part of the design validation. So if no changes were required…[Read more]