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Angela Mallery

Angela Mallery, EdD

Principal Product Development Strategist  

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Angela has worked within the medical device industry for over 20 years for companies such as Zimmer, American Medical Systems and St Jude Medical before she turned to consultancy. At NAMSA, Angela works with innovative medical device companies to assist them in the development and implementation of regional and global regulatory strategies. This experience encompasses regulatory work for U.S.-based Sponsors for Breakthrough and Step submissions, introduction and complex pre-submissions, 510(k)s, IDE submissions and PMAs. Her expertise also includes working with EU manufacturers on Technical Files and Design Dossiers.

CORE COMPETENCIES

  • Develops regulatory strategies for novel and next generation medical devices to address regulatory, reimbursement, and business needs
  • Assists in developing regulatory strategies for small companies to make them attractive for acquisitions
  • Acts as Program Director for complex regulatory projects to ensure timelines are met
  • Develops regulatory strategies that include pre-sub strategies with the U.S. Food and Drug Administration (FDA); helps companies through the pre-sub process
  • Serves as a stand in for Sponsor’s Regulatory VP role, including interviewing staff, assisting in recall strategies/FDA warning letters and 483 issues
  • Reviews device/design changes and serves as an independent reviewer for product development
  • Develops, writes and presents pre-submission information to the FDA, including Breakthrough designation, pre-510(k)/IDE/PMA/HDE, submission issues meetings and supplements
  • Has received Breakthrough and/or Safer Technologies Program (STeP) designation on 10+ devices
  • Creates CE Mark submissions for class I, IIa/IIb and III devices, and updates/changes
  • Other submission experience includes: Clinical and device submissions for Heath Canada and Brazil, Japan, Australia and New Zealand
  • Serves and presents on industry panels and workshops with the FDA to discuss regulatory and clinical strategies, and Breakthrough, EFS and IDE programs
  • Establishes frameworks for Quality Management Systems (QMS) for new businesses, including writing procedures and training
  • Plans verification and validation strategies and creates plans for project teams, establishing compliance to device-specific standards, quality standards, and internal processes and procedures

RECENT PROJECTS

  • Recent projects include work on neuro stimulators, surgical mesh to prevent tissue attachment; drug delivery systems for gene therapy and nanoparticle devices