Regulatory & Quality
Medical device regulations are complex. Genesis has the experience, resources, and quality system required to execute successful regulatory strategies, including FDA 510K, DeNovo, and PMA clearances.
Direct Experience Matters
Several members of our engineering and founding team have extensive experience in navigating the FDA regulatory process, both within highly-resourced corporate contexts and for small entrepreneurs. Our team’s experience includes:
Class I Medical Devices
Lower risk devices like bandages and manual surgical instruments
Class II Devices
Moderate to high risk devices like permanent and resorbable implants and instrument systems. Devices that already have a predicate on the market to be compared against
Class III Devices
High risk devices, critical to sustaining life such as circulatory or respiratory management devices, and orthopedic implants without a predicate to compare it to, or devices combined with a pharmaceutical material.
Quality first: ISO 13485
Critical to the regulatory pathway is a solid quality management system. Genesis operates with an ISO 13485-2016 certified quality system. This efficient and streamlined system ensures that all types of medical devices and teams engaged with Genesis are aligned toward meeting FDA requirements.
Preclinical Studies
Genesis and our strategic partners are able to design and execute both GLP and non-GLP studies which derisk emerging technologies, preparing for their regulatory clearance applications. Our resources are situated both domestically and abroad, allowing Genesis to select the appropriate experts to engage the most innovative solutions.
Tyler Braketa, Vice President of Quality
"Quality and Regulatory are critical functions for ensuring patient safety and product efficacy within medical devices. Regulatory bodies, such as the FDA, establish stringent guidelines that manufacturers must follow throughout the product lifecycle- from design and development to post-market surveillance.
Our quality management system aligns with ISO 13485 and 21CFR820, which plays a vital role in maintaining consistency within our development process and compliance throughout the process. By integrating quality and regulatory requirements early in the device life cycle, manufacturers can navigate complex challenges, enhance product reliability, improve patient outcomes and align with the quality and regulatory vision of the potential acquisition partners."
