Forum

Notifications
Clear all

What are Design Controls?

106 Posts
97 Users
0 Likes
9,782 Views
(@monicagoncalves)
Posts: 59
Trusted Member
 

The 9 parts of design controls are extremely important because it identifies constraints, reduces risks, and guides project management and engineering team from concept to product; planning, input, output, review, verification, validation, transfer, design changes, and design history file. The purpose of design controls is so that the company follows steps to produce a good product that is coherent to design methods, is ethical, and doesn’t hurt anyone. Every part of the design control requires a document; DHF, PDF, DDP, DID, and DSD. The reason for the documents is to make sure that everything done during the project is written, implemented, and able to be reviewed by the team, FDA, or outside sources/managers.

 
Posted : 12/11/2017 5:37 pm
(@rd389)
Posts: 46
Eminent Member
 

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices).

Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

Source:
Design Control Guidance For Medical Device Manufacturers. (2017). Fda.gov. Retrieved 13 November 2017, from https://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm

 
Posted : 12/11/2017 7:08 pm
(@woolynn)
Posts: 36
Eminent Member
 

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices). Design control is a set of quality practices and procedures.It controls the design process to assure that the device meets: -User needs, -Intended uses, and Specified requirements. It can improve and prevent future issues.

 
Posted : 13/11/2017 8:28 am
 Sk90
(@sanam)
Posts: 109
Estimable Member
 

Design controls are important for ensuring that medical device is safe and effective and meets user 's needs and requirement. However FDA design control regulations applies to class III and class II and also some class I devices , every medical device company should follow basic set of design control whether they are making simple deice or a complicated one. Its key elements are design input ,design output, development planning, design verification and validation, DHF. Design control helps to detect and fix the error at an early stage. Properly designed design control helps to improve medical device and prevent issues and problems in device . Design control requires medical device manufacturer to keep documents and records during the development phase to make sure design is safe.

 
Posted : 29/10/2018 6:31 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

Design Controls are a critical component of every project and provide the necessary checks to ensure that all devices are safe for use and meet their intended use. Design Controls will monitor the steps that you take in designing and creating your device to ensure that no necessary steps are skipped, that enough time is taken on each step to ensure completeness and accuracy and that everyone is following the same procedure to keep everything regulated. Documents such as the DDP, DID and DSD help project teams by making them clarify exactly what they need out of their device, to help them set their own standards that the FDA believes to be necessary, and helps keep project teams organized. By making project teams stay extremely organized, all important and useful information can be used to verify and validate the device, and can be used to eliminate potentially dangerous of useless devices. These documents make it easier for the FDA to approve devices as they have a template to matchup and compare your device too. This order makes it so devices can get approved quicker and can be put out on the market quicker. It also ensures safety with multiple documents and checks along the design process to make sure the device will not injury or cause harm to the patients.

 
Posted : 29/10/2018 11:07 am
(@lurongyang)
Posts: 33
Eminent Member
 

Design Control is a broad definition of illustrating how you monitor the design process before it goes to the FDA for auditing. There are overall 9 files that should be accomplished: Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File.
From the perspective of a company, this is a very necessary thing to start with when you wish to develop a new product whose function is consistent with your design, the demand from the market, and no moral issues. From the official organizations such as NIH or FDA, the design control has to be formally assessed for every new applications to ensure the safety use and verification.

 
Posted : 02/11/2018 10:59 am
(@mb698)
Posts: 83
Trusted Member
 

Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical device. It is important because the product designed should be safe to efficient to meet the consumers need and wants. Design control is important because the developer can make changes in the design before it is too late. It is useful when time spent on it too little on the development of the medical device.

 
Posted : 02/11/2018 6:30 pm
 hzy2
(@hzy2)
Posts: 39
Eminent Member
 

Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets customer needs. In 1984, FDA identified lack of design controls as one of the major causes of device recalls. Having good design controls during product development stage decreases the chances that the product will be recalled from the market and prevents the company from losing money associated with that particular recall. Some elements included in design controls are design inputs, outputs, verifications, reviews and validations. Some of these elements are pretty similar to what we did in our capstone class where we wrote product requirements documents depending on customers' needs and test plans that we later used to test if the product we developed throughout the course meets those requirements.

 
Posted : 04/11/2018 1:49 pm
(@devarshi-joshi)
Posts: 68
Trusted Member
 

Set of quality practices and process are defined as design controls. To assure that it meets user needs, intended use and requirements. It monitors and ensures no steps are skipped and enough amount of time is given to each step to complete accurately. Some documents like DID, DSD, etc helps teams clarifying the needs and provide the exact product. By making teams all important information is validated and verified and helps in eliminating dangers. And so these things makes easy for FDA to approve any devices. This helps for a device to get approved quicker and sent to the market quicker.

 
Posted : 04/11/2018 6:45 pm
(@dkonara921)
Posts: 75
Trusted Member
 

A good way to think about Design Controls is that it is a systematic approach that is used for one main purpose: to ensure that a developed complies with the imposed regulations. It describes the entire process in which a concept or idea is brought into fruition by developing a tangible product that complies with certain rules and limitations. The order of the steps in Design Control is pretty straightforward and it makes sense logically why each step is placed the way it is in the sequence. In my opinion, the most important thing that must be applied in any part of the medical device development process is documentation. Documenting all of the major activities is extremely important because this can help avoid legal liability and can help expedite the process. Furthermore, it can prevent mistakes going forward because the more documents you make, the more you have to refer back to you if you need help moving forward in the process.

 
Posted : 04/11/2018 7:13 pm
(@gsharma)
Posts: 34
Eminent Member
 

Design Control states that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met. It sets practices and procedures to assure that the device meets user needs, intended uses and specific requirements. Design control is about planning, design execution, testing against specifications and requirements, and uncovering and fixing problems at an early stage. It guarantees that the product will meet the regulation requirements through the following key elements: design & development planning, design input, design output, design review, verification, validation, transfer, design changes and design history file.

 
Posted : 05/11/2018 12:42 pm
 Fp55
(@fp55)
Posts: 39
Eminent Member
 

Design controls are to demonstrate that a product completes the user needs, meets inputs and requirements, is proven to meet the standards, and meets the performance criteria.
The FDA clauses for Design Controls and ISO 13485:2016 clauses regarding Design & Development are almost identical. Each require that your design controls consist of design planning, inputs, outputs, design review, design verifications, design validation, design transfer, design changes, and design history file. It is very important to establish and maintain traceability through out the project. Done correctly, traceability will show the relationship and linkages between all of the design controls listed above.

 
Posted : 06/11/2018 3:06 pm
 dfn3
(@dfn3)
Posts: 78
Trusted Member
 

I agree with this point. When it becomes too much for the company they use the design controls as something they just need to get done, they do not use it to benefit their product. It becomes tedious work instead of benefitting the product. Then they begin to rush because they just want to get the paperwork done and they do not focus on actually making their product better. Once they stray away from the design controls everything becomes different and their final product might not be anything like the original one they wanted to make. Because of this they might not be consistent with what the company actually wants to make.

 
Posted : 07/11/2018 9:09 pm
(@dsk35)
Posts: 38
Eminent Member
 

The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA needs a way of mapping out exactly how your product was made and the steps you took to make it. It is also a way to back track if something goes wrong and to see if there are aspects of the product that could be changed to prevent future malfunctions.

 
Posted : 08/11/2018 5:17 am
(@mem42)
Posts: 40
Eminent Member
 

Design controls have a specific objective and its to assure that the device meets the user needs, intended uses and specified requirements. Design controls also serve as a way to continue improving the device and prevent future problems, FDA callbacks. Most of the callback cases that occur are related to non-conforming materials. The design control of a product must begin right after the design of the device begin and it must stay consistent throughout its development and even when it has been released to the market. By having the consistent design controls we can avoid major issues relating to the user specifications and FDA callbacks.

 
Posted : 11/11/2018 11:53 am
Page 3 / 8
Share: