Regulatory
and Quality
Our experienced regulatory team specializes in guiding products through the FDA approval process and providing actionable options for determining the best approach for your product. We collaborate closely with your team to expertly navigate the regulatory landscape, ensuring long-term success for your product.
Expertise areas
Regulatory Strategy
Crafting an approach to ensure that a client's device meets regulatory FDA requirements and in-line with the device's desired intended uses and indications for use. The strategy typically addresses regulatory landscape assessment, class and classification of the device, regulatory and quality management system (QMS) requirements, preclinical and clinical studies, regulatory submissions, engaging with FDA officials, and managing post-approval obligations to ensure product safety, efficacy, and compliance throughout the product lifecycle.
Design Control and Risk Management
Following a regulatory compliant and systematic process for the development and manufacture of medical devices to ensure they meet specified requirements and are safe and effective for their intended use. Risk Management identifies, assesses, and mitigates risks associated with devices throughout their lifecycle. It aims to ensure that risks are understood, managed, and minimized to an acceptable level to enhance the safety and effectiveness of the device.
Product Class and Classification Determination
Researching options to assign a specific regulatory category or class to a product based on its intended use, indications for use, technology, and potential risks. This determination is crucial for regulatory compliance and ensures that products are appropriately regulated and marketed.
Quality Management Systems
Implementing a structured framework of policies, processes, and procedures to ensure consistent quality and compliance with regulatory requirements throughout an organization. Includes Standard Operating Procedures (SOP's) and, for regulated medical device development, is required and auditable if you are certified.
FDA Q-Sub Preparation and Support
Supporting clients seeking regulatory feedback and guidance from the FDA during the development process, such as feedback on specific questions related to product classification, regulatory submissions, clinical study design, and other regulatory requirements and inquiries. This includes compiling data such as preclinical and clinical study plans, product descriptions, proposed indications for use, and manufacturing details, and crafting a clear and concise submission package with the specific feedback being requested.
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