Risk Management and Design Control

Do you understand how risk management strategy impacts design controls? Join Dr. Steven Coulter as he presents an in-depth overview of the Waterfall design model and addresses the question, Are Risk Management and Design Controls two different processes? You’ll learn more about incorporating risk management strategies into user needs and design inputs, as well as how validating both will accelerate the success of your design review process.  About RCA Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for the resolution of life science challenges: Life Sciences Pharmaceutical Biologic & Biotechnology Sterile compounding Medical device Lab Testing We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience. Founded in 2000 Headquartered in Wisconsin (USA) Expertise backed by over 500 industry subject matter experts Acquired by Sotera Health in 2021 About Sotera Health The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion®, and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year. We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies. Follow the link to begin the Regulatory Compliance Associates® scoping process today. https://www.rcainc.com/contact-us/