Regulatory Globe offers Expert Regulatory Affairs strategies and helpful implementation tools for medical devices. Stay updated with EU MDR, IVDR and more.
When you need seasoned regulatory affairs leadership on a significant project such as the transition to EU MDR, we’ll provide trusted leaders to put your mind at ease. Project Management For large projects, RQM+ project managers work with you to define the scope, develop the plan and schedule...
Keep medical devices on the market Medical device regulatory affairs tracking software Regulatory Watch helps you get the latest updates on regulatory changes and guidance pertinent to your medical device. Find the updates that are relevant to your device, IVD or product — access all updates from ...
Explore comprehensive medical device consulting services at Med-Di-Dia, specializing in regulatory compliance, CE marking, and market access, Med-Di-Dia offers expert guidance on MDR 2017/745, IVDR 2017/746, FDA submissions, and more to ensure your medic
Navigating Regulations, Ensuring Innovation: Your Trusted Medical Devices Regulatory Experts Market Access Implementing strategies to navigate regulatory pathway to effectively introduce your medical devices into target markets. . Regulatory Affairs Ensuring compliance with regulatory requirements to ensure the saf...
If you are a part of the Medical Device Regulatory Affairs community, TT RA guarantees a valuable return on time invested.
Our expansive regulatory affairs experience in the United States, European Union, United Kingdom, Japan, Canada and other international countries across medical device therapies enables us to help clients achieve long-term business objectives and expand into other global markets. ...
FDA regulatory affairs: a guide for prescription drugs, medical devices and biologics. 2nd ed. New York, NY: Informa Healthcare USA, Inc.; 2008.Pisano DJ, Mantus DS. FDA regulatory affairs: a guide for prescription drugs, medical devices and biologics. 2. New York, NY: Informa Healthcare...
Regulatory AffairsWe are committed to accelerating the development and marketing of medical and health products for the benefit of patients. We can provide registration and regulatory consulting services covering the whole life cycle of medical and health products, including pharmaceutical products (small ...
Regulatory Affairs (RA) is Regulatory Compliance Associates (RCA) backbone when it comes to regulatory compliance. We handle more medical device regulatory affairs consulting submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, MHRA, EMA and not...