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 Directive. Both documents are methods of design control. The biggest difference is the FDA looks are the history of the 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 method of fulfilling DSD-like characteristics. I personly like the structure of the DSD document rather than the…[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 75 percent do. This is due to the evaluation of the actual risk of the product and the intended use. The EMA uses a scale of Class IIa…[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 be useful to follow. As per my additional research, they can go through a consultation process with multiple…[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 of conception. These files feed into the 510k and technical files but are itself a hefty file of design…[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 Uniform Commercial Code governs contracts involving the sale of goods. It requires that contracts for the sale of goods over…[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 very unethical topic especially in the medical field. “Gifts” are a great technique to do business with, but fields like healthcare…[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 will lead to more of a compensation and damage control and hopefully a payout if proven. Whereas patent law is a…[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 company and how they are and act. This has a direct effect on their performance and…[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 and project manager. The need to find constant compromise can be taxing. Another is sharing…[Read more]

Depending on the size of the company, its resources and number of projects the company holds can influence the best type of organizational method. For smaller businesses a project bases organizational structure I think works best. Project organizational structure refers to the creation of an independent project team, they have their own technical…[Read more]

I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in its intended use. There should be a risk analysis on aspects of what would occur if the product was used incorrectly in various degrees. Obviously if…[Read more]

I also agree with the 4th example being a very important aspect of risk management. When a company conducts it own identification of risks and test they try to be very thorough. However, a company cannot identify all risk and issues which can arise with the product under various unknown circumstances. Therefor processes like change orders address…[Read more]

The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed done on the product,and also to the subscription of forms and services. As the FDA’s job is to make sure the processes are done properly and safe…[Read more]

I have not been part of designs review in industry. However, last year a group of BME students and I applied for a URI grant and wanted to start our own project. We had design review meeting for each stage, first for our design schematic, second after the finalization of our parts and projects designs and again after reaching each milestone. These…[Read more]

I am currently Senior at NJIT taking my Capstone class, which is our senior design class. The purpose of this class is to simulate real-world medical device processes to produce a product. Our professor look at our Gantt chart to assess our progress and observe whether or not our milestones have been reached. The reason why I like the…[Read more]

Design controls designates the application of a proper process or method for the developmend of a product. It is mandatory to implement controls when designing and developing products within regulated industries such as medical devices. “The Food and Drug Administration has required that medical device manufacturers that want to market certain…[Read more]

I am currently a senior in Capstone. The procedures that we are exposed to when it comes to Customer Needs, Business Requirements and test plan is meant to mimic that of the industry. Formatting that class in more of an industry device development vs academic research is very beneficial t student. I myself have been involved in a lot of academic…[Read more]

Being preparing for an audit is the best way to tackle an assessment. The first way to prepare is to actively start early. As DHF is being processes starting your traceability matrix from day one will make is a lot easier to prepare for the Audit. An audit can happen at anytime and being ready for it at anytime can save a lot of time and stress.…[Read more]

Taking minutes is an important aspect of meetings. The biggest legal reason of minutes is that it can be considered as a legal document. The minutes contain the action of the company and important action details. This means that this document can be audited and it can either help or harm the cause with the company. Minutes also serve has an…[Read more]