Enabling better health
CardioMed Device Consultants LLC
CardioMed Device Consultants, LLC is a US based medical device consulting company focusing on US regulatory, pre-clinical and clinical studies. CardioMed is an expanding group of professionals with over 100 years of combined experience working in the field of medical device and combination products development, evaluation, and review. Many of its principal members are former employees of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). This strategic relationship will enable ( your company ) to offer services in the US through our partnership.
Hoodin aims to simplify monitoring of digital content by offering the opportunity to automate the entire process. The Hoodin SaaS plattform and robots monitor and collect the information from sources relevant to a specific industry, and gives the user access to the found content via the Hoodin platform.
What makes Hoodin unique is that they offer a customized solution for each customer based on their industry and specific needs, and also that Hoodin is designed to monitor so much more than just news and social media. This ensures maximum benefit and relevance to the user. Using the platform also saves you a large amount of time, which gives more time to focus on other business values. For Medtech companies, Hoodin offers the solution Omni Observer for Medtech. With that solution, companies may automate a large part of the work lodad related to Post Market Surveillance.
Obelis Group is a quality driven, service oriented company based in Brussels, Belgium with over 30 years of experience in regulatory affairs. Obelis operates as one of the largest regulatory centers in Europe today, providing CE marking advisory services and Authorized Representative (EC REP) services.
Eminence Clinical Research, Inc.
Eminence Clinical Research, Inc. is a premier consulting firm that provides a complete CA-RA-QA infrastructure to start-up medical device companies. We provide clinical research, data management, biostatistics, EDC, reimbursement, regulatory submissions, quality assurance, medical writing, and interventional suite/operating room procedure support services. Our experts provide strategy and tactical expertise working with the US FDA to efficiently bring your products to market. Let our clinical liaisons partner with you to support your medical device procedures from First-in-Man to IDE through US Post-Market Product Launch Support to ensure proper conduct of your research or post market medical device procedures.
The Information Platform on the EU Medical Device Regulations is the most extensive and up-to-date information datebase on European MDR and IVDR laws. Find all relevant guidance documents, templates, checklists and recent regulatory updates in one place and prepare for a smooth transition to the EU MDR and IVDR. Check the membership plans or one-time purchases to personalize your experience at MDlaw!