I agree with hm243 that a reevaluation has more benefits than pitfalls when observing the various location of equipment use. However when multiple locations are set and frequent then a complete evaluation may not be necessary. If the equipment is…   Read more»

I believe is always beneficial to be proactive rather than reactive. In a reactive system you solve matters as they arise, this can lead to possible beneficial changes. However, solving matters before they become an issue will generally lead to…   Read more»

I agree that technical writing is an essential skill that all engineers should have. Mandating classes that help students practice this skill will be a long-term benefit. Most communication especially interdepartmental paper-work uses written documentation as a primary communication tool….   Read more»

I may be misunderstanding your question, but revised documents should always be updated. If any other document references the changed document, then that document should also be checked for any necessary changes. No document should be outdated, especially in a…   Read more»

The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process is tailored to each device. The customer and user need to be complied with. The safety and outcome…   Read more»

The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency. Keeping that in mind I believe that the organization that utilizes the 5 different…   Read more»

A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, proper protocol is very important. Therefore an ECO was issued due to the change in the…   Read more»

When writing SOPs, detail is very important. Your manager is correct, a random person should be able to complete the procedure. However, the in-depth details should also be concise. A concise and detailed procedure is more efficient that unnecessary words….   Read more»

SOPs contain the regularly recurring work processes that are to be conducted within an organization. It states the activities that are to be performed to facilitate consistency.The use of SOPs minimizes variation and promotes through repeatable results. These guidelines are…   Read more»

I agree with your method of using a regression test to save resources. But this might not always identify the issue. By using a less involved method first and then later a more involved re-executing full verification and validation protocols…   Read more»

I believe comparing the two documents and ranking them in terms of more usefulness might not be the best because the DHF is used widely by the FDA and Technical File and Medical Device (MDD) are for the Medical Device…   Read more»

The company the I work for uses a similar document that you stated. Using an excel spreadsheet with necessary columns to fulfill. I believe the method or specific document used can be irrelevant if the company uses their own efficient…   Read more»

The one big difference in classification I see between the FDA and the EMA is the class II classification. In the US, around 25 percent of the class II devices do not go through a clinical trial, whereas the other…   Read more»

I believe the Guidance MEDDEVs is an important guideline. First and foremost they are drafted by the proper authorities that are in charge of being a safeguard for the public health, and guidelines that have that in mind will undoubtedly…   Read more»

There are big differences between the Design History File, 510k Submission, and the Technical File. The design history file is an FDA regulation that talks about the design controls and the changes and additions that have occurred from the time…   Read more»

When it comes to business then verbal contracts should never be considered. Fighting this in court is very difficult when it turned into a he said/she said. One way to prove is the proof expenses and proof of services. The…   Read more»

I do not think this is an over-restriction. These types of restriction are needed to keep the overall benefits in mind, instead of doctors being influenced by gift. The gift can easily be seen as bribes and this is a…   Read more»

An NDA is a contract of confidentiality, where a patent is a protection of intellectual property. Contracts are enforced differently in various states and very much matter solely on how well it is written if the contract is broken: it…   Read more»

Corporate culture represents the professional values a company adopts that dictate how it interacts with employees, vendors, partners and clients. An effect organization in a corporation can lead to a positive company culture. Culture relates to the people of the…   Read more»

As a project manager, I believe a matrix organizational style would be the hardest or a more involved method to execute. The first aspect that makes this a more difficult organization is the presence of constant tensions between functional manager…   Read more»