Blur is a full-service product development firm that offers a comprehensive range of product development services to help turn your ideas into reality. Product development isn’t just about bringing a product to market. It’s also important to ensure that your product complies with regulatory requirements. 

That’s where our regulatory services come in.

Regulatory guidance is crucial to the development of any medical device. By providing essential design controls and testing from the outset of the design process, regulatory guidance can help ensure that a product meets regulatory requirements and achieves market clearance more quickly.

The first step in obtaining regulatory guidance is to determine the classification of the product and the appropriate regulatory strategy. This will help identify what types of testing are required, including verification testing, validation testing, and usability testing. In addition, it will identify any applicable standards and guidelines that must be followed to ensure compliance and streamline the product development process.

Ideally, regulatory guidance should be involved in the very beginning stages of product development. This ensures that the device is classified correctly and that the appropriate regulatory strategy is identified. It may also involve a pre-submission with the FDA to review and discuss questions that may arise during the development process.

Throughout the product development process, regulatory guidance ensures that testing protocols and test reports meet the required standards to produce high-quality submissions. Additionally, it ensures that appropriate product development documentation is maintained to address any questions that may arise from the FDA.

Regulatory Services: Navigating Regulatory Compliance with Ease

At Blur Product Development, we understand that regulatory compliance can be a daunting task for most in the medical device product development field. Fortunately, our regulatory services team can help you navigate this process with ease. We offer a comprehensive suite of regulatory services, including regulatory guidance, compliance assessments, and FDA submission support. Our team of experienced regulatory professionals can help streamline your product development process, saving you time and money.

With our regulatory services, you can rest assured that your product will meet all the necessary regulatory requirements, allowing you to focus on what you do best – developing innovative and high-quality products that improve people’s lives.

To get started, we arrange a call to discuss your needs and learn more about your product. We help determine the appropriate regulatory strategy and how we can assist you in achieving market clearance quickly and efficiently.

Ready to take the next step with your product development process? Contact us today to learn more about our product development and regulatory services.