Affiliates

Annette has been a regulatory affairs consultant since 1998. Prior to consulting, she was Director, Regulatory Affairs, for Critikon, a Johnson & Johnson Company, where she worked with cardiovascular monitoring devices. She has over 25 years experience in regulatory affairs, compliance and clinical affairs with prior experiences in the implantable cardiovascular and ophthalmic devices industries. Her worldwide regulatory affairs responsibilities have included FDA submissions, GMP/QS compliance, interpretation of all FDA regulations and policies, regulatory representation on new product development teams, product liability and international product registrations.  She has also represented Johnson & Johnson on several software related FDA/industry guidance and standards-setting activities.

Annette is Regulatory Affairs Certified and holds BA degrees in biology, microbiology and secondary science education.

Led the first AI-enabled De Novo approval of SaMD.  Former Chief Quality and Regulatory Officer, Management Representative under ISO 13485, Person Responsible for Regulatory Compliance under EU MDR, Lead auditor for ISO 13485 (MDR, MHLW Ordinance No. 169), and supports Mass Gen Digital CRO strategy and planning related to FDA submissions.  Senior expert with pre-subs, De Novo and 510(k) submissions, strategy, FDA negotiation and interaction.

Karen is an extremely talented regulatory affairs consultant and university assistant professor. Her expertise covers US, Canada, European, and global regulatory regulations.  In addition to her teaching role, she has worked in medical device companies driving regulatory and quality management systems.  She is trained in auditing across the quality management systems. 

Karen holds her Juris Doctor from the University of Maryland School of Law as well as undergraduate and graduate science degrees.

Software requirements review, creation and remediation. Test documentation, manual and automated test development, and test execution. Software validation as it relates to 21CFR820, 21CFR820.70(i), 21CFR820 Part 11, and IEC 62304.

Cybersecurity quality management procedures review, cybersecurity risk analysis, threat models, etc.

Robert is a former Principal Scientist with GE Healthcare and has 40+ years’ experience in medical device software and systems development.  He as designed and implemented ECG, blood pressure, and other signal processing systems in research and product development settings.  He has a long track record of understanding quality assurance, both from a compliance perspective but also from success at delivery production-ready, robust medical devices used globally.  Robert is a member of  the AAMI Sphygmomanometer Committee, AAMI ECG/Arrhythmia Monitoring Working Group, and AAMI ECG/Ambulatory Electrocardiograph Working Group.

Tom has spent over 25 years developing medical device and commercial software systems.  Tom was on the front end of server-based web applications serving many commercial sectors and helped many of his clients enter the mobile-cloud platform world.