SOFTWARECPR - Key Persons
Software & Quality Systems regulatory crisis management and FDA negotiations including recovery from import detentions, injunctions, consent decree negotiation, requests for consultant certifications, warning letter responses, and more.
Job Titles:
- Regulatory Associate / University of Florida
University of Florida Levin College of Law graduate with experience as an educator and in regulatory affairs, medical device quality systems, and design controls.
Job Titles:
- Regulatory Affairs Consultant
- Regulatory Affairs Expert
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.
Full service regulatory consulting, including FDA interaction, standards compliance, lean/agile medical device software processes, expert with IEC 62304, IEC 80002-1, AAMI TIR45, software hazards analysis, verification and validation testing, training, coaching & mentoring.
Dr Rech has over 20 years experience in systems and safety engineering in regulated industries in individual contributor and management roles. He has worked with Class II and III medical devices including implantable pacemakers, infusion pumps, and remote monitoring devices and apps. He held certificates as INCOSE Certified Systems Engineering Professional and TUV Rheinland Certified Functional Safety Engineer. He holds a Doctor of Philosophy (PhD), Physical Chemistry, Free University Berlin, and speaks English, German, and French.
Ginny is a regulatory affairs professional specializing in software-based products starting in 2011. She has experience in the regulated industry including medical devices, pharmaceuticals and biotechnology.
Ginny has developed regulatory strategies for a variety of SiMD/SaMD and AI/ML-based products during her career at start-ups, mid-size companies and global enterprises. She has worked on US regulatory submissions including Q-Sub, 510(k) and PMA and has supported a variety of global submissions. Ginny is known for both strategic and tactical support including hands-on, close collaboration with frequent-release agile development teams. Ginny's professional objectives are driven by her personal goal to expedite the development and approval of quality medical products into medical markets.
Job Titles:
- Partner / Expert With Embedded Software Process and Methods, Test Engineering, Design Transfer
Expert with embedded software process and methods, test engineering, design transfer.
John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483's, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.
Jordan provides a broad range of technical support including BA roles such as reviewing/refining stories and/or requirements, reviewing/refining traceability analyses and reports, software test protocols and test case review/refinement/examples. Experienced with agile dev team environments and the use of tools such as JIRA, X-RAY, etc. Jordan also can perform IEC 62304 and ISO 14971 audits, assessments, and first level remediation work with requirements, architecture, plans, and test assets, electronics/mechanical technical and construction of test fixtures, and test automation support.
Jordan brings a wealth of risk management experience as a practitioner and leader. He works daily with clients to ensure compliance with standards and FDA expectations.
Job Titles:
- Regulatory Affairs Consultant
- Regulatory Affairs Expert
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.
Assessments/ implementation of least burdensome FDA/ISO13485 compliant QMS, design controls, SDLC. IEC62304 process; software risk management; TIR 32 committee member. Drafting software submission information.
Mike is an expert in business agility and is key to our "agile and compliant" process transformation and improvements. Mike served on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software. Mike combines experience serving as both a C-level executive, including as Chief Operations Officer for a top 60 U.S. bank, and as a trusted advisor to CEOs and other top executives at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing executives today, especially with rapid change and digital transformation. For example, while leading a product division, Mike introduced changes that resulted in improved productivity by 15%, cut time-to-market by up to 67%, and reduced defects by over 50% in flagship products processing of over $80 billion in financial transactions per year.
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.
23 years experience in medical device software development and management focused on large, complex systems with multiple computing systems containing all safety classes of software.
Risk based code review and real-time embedded software analysis of medical device. IEC62304 software requirement, design, V&V testing processes for FDA, ISO14971 risk management.
*Note: Partner is a title describing a branding and marketing partnership and does not indicate ownership or corporate structure.
Medical device software standards expert, IEC 62304 and IEC 60601-1 PEMS chairman, IEC 80002-1 medical device software risk management, IEC 80001-1, safety cases.
Job Titles:
- Mobile & Cloud Software Expert
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.
Job Titles:
- Regulatory Affairs Expert
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.