Rules are rules, but are they always necessary? Short answer: Yes!
Comprehensive regulation and standards have reshaped the medical device and drug landscape by improving the efficiency of the product development process. They ensure your product functions according to its intended use and keep the end-user safe.
Following regulations/standards and having a robust QMS, cuts down on manufacturing delays and product recalls, saving you time and money.
In this free webinar presented by Isabella Schmitt RAC, Director of Regulatory Affairs at Proxima Clinical Research, you will learn how regulations, standards, and a QMS all come together to create a better, safer product and improve your bottom line.
History Before Regulations – Learn how regulations reshaped the landscape of medical product development.
Standards vs. Regulation – The connection, overlap, and how these two influence one another.
Quality to safer devices – Learn how monitoring and maintaining standards improve efficacy and efficiency in manufacturing safer products.
Pre-market requirements – Here’s what you need to know before your product gets to market, including developing QMS and Design Controls.
Post-market requirements – Is your product already on market? Here’s how to use PMS and what else you need to keep in mind after your product is readily available to the public.
FDA and ISO – Learn about the impact of ISO standards how they affect FDA regulation
Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.
You have an innovative medical device or drug, and you need an organization experienced in getting products approved and on the market. We know your needs. We know the pitfalls of the submission process and how to avoid them. From regulatory consulting to clinical research, Proxima is the dedicated full-service Contract Research Organization for emerging companies. Visit their website to learn more.