Medical Devices
Regulatory Strategy & Due Diligence
Biologics Consulting is a consulting firm, with a highly experience dedicated team that focuses on medical devices and IVDs (In vitro diagnostics). We provide regulatory strategy and Quality Systems guidance to a wide variety of medical device manufacturers responsible for developing and manufacturing a wide variety of medical device types, from small start-up companies to large publicly traded companies.
Our medical device development team has extensive knowledge and hands-on experience with hundreds of successful projects and initiatives. Biologics Consulting offers global medical device expertise that gives you an edge.
We bring together innovative approaches, world-class science, regulatory know-how and a dedicated team to deliver medical device regulatory design and development solutions that make a positive impact on public health and quality of life for patients.
Guiding You Every Step of the Way
- Provide short- and long-term regulatory strategies for medical devices, IVDs, and combination products
- Serve as expert witnesses
- Conduct due diligence assessments
- FDA meeting preparation, representation, and engagement