Since 2005 NDA Partners has served many companies in the medical device industry. Our clientele is national and international, and our combined experience includes several decades at FDA's Center for Devices and Radiological Health, and regulatory leadership with medical device companies. We have expertise in a wide variety of technologies and clinical disciplines such as orthopedic, cardiovascular, in vitro diagnostics, including companion diagnostics, general and plastic surgery, urology, tissue and cell-based engineering, and combination products (device/drug and device/biologic).
The Device Team at NDA Partners can provide regulatory support for small companies, helping provide and build regulatory capacity. For companies of any size, the Device Team can augment capacity at 'crunch times' and work as part of the company's regulatory team to build and execute strategies when problems arise.
NDA Partners expert services include:
- Business development and due diligence
- Strategic assessment of product classification, regulatory pathways, leveraging data systems, global submission platforms, labeling, bioresearch monitoring, promotion and advertising
- Pre-submission meeting preparation, including development of briefing documents, meeting materials, rehearsals, and post-meeting follow up
- Pre-Market submission [510(k)/IDE/PMA/BLA] preparation, and process support
- Design of pre-clinical and clinical studies
- Appropriate application of recognized standards
- Quality system audit preparation and response
- Enforcement assessment and response
- Correction and removal assessment
- Risk management across the life cycle from design controls to vigilance
- FDA Advisory Panel preparation, rehearsals, meeting support and follow up
- Litigation support and expert testimony