Offering a broad perspective on the challenges that face large and small, US and international clients throughout the product life-cycle when commercializing medical devices, in vitro diagnostic, digital health technology, and clinical decision support software (including AI/ML-based systems and cutting-edge technologies like AR/VR)--from handling legal and regulatory policy matters to developing regulatory strategies and market authorization support to implementing and remediating quality systems for post-market compliance. Typical client engagements include:* Supporting new product planning* Developing pre-clinical and clinical research strategies* Building, auditing, and improving quality management systems (consistent with ISO 9001:2015, ISO 13485:2016, 21 C.F.R. Part 820, ISO 14971:2019, and IEC 62304:2006/A1:2015)* Performing process and resource mapping and improvement assessments* Advising on CAPA, complaint handling, and MDR/adverse event reporting best practices* Drafting and advising on supplier/quality agreements* Developing and managing premarket regulatory strategies* Drafting and advising on premarket submissions (e.g., IDEs, Q-Subs, 513(g)s, 510(k)s, De Novo Requests, PMAs)* Conducting comprehensive and targeted quality system audits and gap assessments* Drafting FDA Form 483 and Warning Letter responses and remediation plans* Conducting and auditing 483 and Warning Letter remediation plans* Evaluating promotional materials compliance* Serving as US agent to the FDA on behalf of foreign manufacturers* Advising on import/export regulations for medical devices* Assessing post-market fraud and abuse risk and conformance to ethical standards (i.e., Codes of Conduct and OIG Compliance Guidelines)* Conducting benchmarking studies* Supporting post-acquisition integration activities* Developing and advocating for regulatory policy

Lead a group of organizations in the digital health industry in the development of a standard definition of the term "digital therapeutics".

Supported large and small, US and international clients throughout the product life-cycle when commercializing medical devices, in vitro diagnostic/companion diagnostic, digital health technology, and clinical decision support software (including AI/ML-based systems)--from regulatory strategy development and market authorization support to quality system and post-market compliance to regulatory policy development to M&A diligence support.

Campaign committee to support the election of Mark Edelson to the Baltimore City Council for the First District. http://www.electedelson.com/

Lectures on medical device product development, FDA regulation of medical devices, and intellectual property issues in device development.

* Developed regulatory policy on mobile health technology and clinical decision support software on behalf of the mHealth Regulatory Coalition and the CDS Coalition as well as medical device trade associations.* Advised foreign and domestic companies on FDA clearance/approval strategies and regulatory compliance, including reviewing premarket submission documents (e.g., design requirements, risk analyses, proposed labeling, etc.) and promotional labeling (e.g., websites, press releases, brochures, and other marketing materials) to identify regulatory risk.* Designed quality management systems, compliance policies, SOPs, and codes of conduct for medical device companies.* Counseled clients on the applicability of the medical device excise tax.* Advised device companies on regulatory and fraud and abuse risks associated with promotional activities.* Conducted due diligence reviews of device companies engaged in merger and acquisition negotiations.

* Reviewed proposed and final rules and guidance documents for regulatory compliance (e.g., Good Guidance Practices).* Organized cross-functional team to respond to citizen petitions submitted to the FDA.

* Advised on product development plans for next-generation, implantable cardiac rhythm management devices.* Analyzed clinical data to test advanced algorithm performance.* Drafted reports and publications from clinical study data.

* Planned, coordinated, and analyzed results from clinical and pre-clinical studies to develop and prove the feasibility of automaticity features for new implantable cardiac and neural stimulation devices.* Worked with Clinical and Regulatory Affairs to ensure compliance with clinical trial regulations.* Led a research, marketing, and product development team to define project scope, feature requirements, and intended uses for multiple automaticity features for implantable cardiac devices.* Drafted system requirements, design verification testing protocols, and product development plans.