With companies required to submit a Risk Management Plan (RMP) to presiding medical bodies such as the European Medicines Agency (EMA) and other National Competent Authority (NCA) organizations, it is imperative that your RMP is error-free and well equipped to pass the required standardized checks.
This free RMP template is designed by Kolabtree’s freelance regulatory consultant, Dr. Nare Simonyan, and will act as a reference point when you need to draft an RMP for your new product and bring it to market.
The RMP template covers the medical product’s features intricately, especially its safety and security, and also elaborates on how they will be subjected to constant checks in order to ensure patient safety and risk management.
Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.
Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.
EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.
The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.
Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a "Breakthrough Device" by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.
