Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Quality Engineer, I took part in the verification tests and validation activities. During the verification tests, we had…   Read more»

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can include a Bill of Materials, and what to include and not include in the…   Read more»

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification might already outline the outputs. In some cases, the device output might not be available until after…   Read more»

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory approval, and market access.  If the software is used in a hospital to store patient data, and track their medical history,…   Read more»

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Design Verification, which only checks if the Design specifications are met. In a case where…   Read more»

Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insignificant data, with varying responses. Even in the case where some…   Read more»

I believe that in some cases it’s ok, where in other cases it’s not. In the case of a drug that required an IDE, it might be a good incentive just in case the patient may require additional treatments from…   Read more»

In a double-blind study, both the Investigator and Patient don’t know whether they’re being given the placebo or actual results. In a single-blind study, only the patient doesn’t know what’s being given to them. A double-blind study is better in…   Read more»

I agree that providing clear evidence based data on safety and effectiveness is important for doctor’s and patients. I think that patients want to feel that the product is safe and effective regardless on how the company claims that the…   Read more»

Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either improving current devices, or designing a new one. Product management looks over a project or product life cycle from…   Read more»

I agree that Sales and Marketing are important for Medical Device companies to meet the needs of costumers and deliver their final product to them. Marketing is responsible for delivering the company’s mission and strategy to the costumer, and then…   Read more»

In public companies, shareholders and investors motivate a large portion of the direction that Engineering goes to. In private companies, the management is the main motivation of Engineering and research. You’ll see that in many private companies, such as Space…   Read more»

If I were to start a business, I would first consider how my business would make an impact in the industry, who are the consumers, and how who would invest in my company. There may be a market gap to…   Read more»

I agree that structure in corporations can lead to restrictions in their research goals. For example, corporations are meant to make money, and run by board members and Officers that might not be motivated by research, and only by making…   Read more»

QA and QC often work together, even in the same departments. QA established the baseline requirements, and even makes a lot of the SOP’s. QC does many of the stability tests, and statistical analysis to make sure products and procedures…   Read more»

In my experience, document control can always improve. For example, companies that still use a paper-based system should switch to completely electronic system. This way, documents wouldn’t get lost, and it would be much quicker to find everything. Also, a…   Read more»

I believe that emerging technologies would be very valuable in the field of QA. With the use of AI, quality management systems could improve by more easily detecting problems with the systems to prevent audits from finding. This way, the…   Read more»

As a Quality Engineer, I had to the opportunity to perform tasks within Quality Management such as approving and modifying SOPs that adhere to GDP, and making CAD specification drawings for all their parts used in their Diagnostic/Detection Test kits….   Read more»

For higher class devices, more extensive clinical trials are needed to investigate the risk and effectiveness of a new device. For class 1 and 2 devices, they must go through clinical trials to demonstrate the effectiveness and safety. For the…   Read more»

I think that newer technology facilitates more efficient Regulatory practices, while also raising more questions. Documents and meetings could be submitted and held virtually, which saves time and costs on both ends of the company and FDA. Newer technology applied…   Read more»