‌ 

Developing a Design and Development Plan is a part of the design controls process required by the FDA for medical device manufacturers[1]. Having a plan in place first will make it so that a manufacturer developing a device will have a much easier time staying compliant. If design and development is not done properly the first-time remediation may be required in order to bring the manufacturer and the device into compliance with regulations. In the worst-case scenario, the FDA might find that the manufacturer is failing to meet the design control requirements for a device and take action against the manufacturer. EMMA International can help explain what exactly is needed for design controls to be compliant.
Planning is a key part of design control not only because it helps set out the steps necessary for designing the device and getting onto the market, but also because it helps establish what documents will be needed for record-keeping. A lot of documents are generated during the design process, a design and development plan will help keep track of which of those are necessary records required for compliance and which are not.
Setting the phases of the design process, what goes into those phases, and what should be expected to come out of those phases is another part of planning. Additionally, each task in a phase would have a person or a team assigned to that task allowing for a clear understanding of responsibilities. In addition to tasks, deliverables, and responsibilities, a timeline should be established as well. Setting a schedule for the process will allow the product to reach the market in the expected timeframe.
Design reviews should be included in the schedule. These reviews would be conducted at the end of each phase in order to move on to the next phase. With approval from the reviewers, the project would not be allowed to advance past its current phase. This is done to ensure that all the necessary deliverables from the phase have been submitted and been done correctly. For example, a testing report may have been submitted but if the report is missing pages or if the calculations were flawed then the reviewers would reject the report and prevent moving forward until the issues had been corrected.
EMMA International is capable of putting an entire Design Control system in place for a company. This includes writing planning procedures that are tailored directly to the company and even helping with the design process. EMMA International provides Full Circle Consulting, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

[‌1] FDA (September 2014) Design Controls, Retrieved 12/18/2021 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/design-controls

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This