The medical device and digital health industries are governed by evolving policy requirements.
Whether you are a small manufacturer/developer or non-profit organization concerned with the rapid changes in global regulatory policy, our team can help you find your voice among the numerous stakeholder groups interested in the regulation of medical devices. Typically, only large manufacturers have the resources to dedicate to influencing emerging policy. We offer an opportunity for a broader set of stakeholders to engage in topics such as the regulation of clinical decisions support software, AI/ML-enabled SaMD, virtual/augmented reality, and other innovative technologies.
Our team assists in developing and advocating policy positions on behalf of industry and non-profit organizations.
Example services include:
• Representing clients on working groups of industry trade associations and in advocacy coalitions
• Engaging with lawmakers and regulators on behalf of clients to promote legislative and regulatory reform
• Drafting comments on proposed regulations and guidance documents
• Advising clients on regulatory intelligence and impact of emerging policy changes on corporate, product development, and regulatory strategies