Do you have multinational experience with medical devices, throughout the lifecycle, and want to give back to the profession by authoring chapters for a new book? This new publication entitled, Global Strategy for Medical Devices, will help your colleagues develop and implement a strategy to successfully bring their devices to the global stage. To be considered, please submit your interest to Pam Jones by 10 April 2014.
Global Strategy for Medical Devices Chapters
Introduction to Medical Device Development
History and background; regulation; acronyms, terms and definitions; interaction with regulatory authorities; is my product regulated as a medical device? where?; in what countries are medical devices regulated today and how is that likely to change in the near future; differences between medicines and medical devices, and corresponding differences in approaches to their regulation; medical device product lifecycle; "borderline products"-medical device vs. medicine vs. biologic vs. personal protective product vs. cosmetic; international regulatory cooperation and harmonization initiatives for medical devices; small vs. large companies
Core Development Team
Team members and contributions to the development strategy-how and when to bring them in; managing a global regulatory team; staffing issues; selling the regulatory strategy and timeline, especially convincing executive management
Setting Up a Quality Management System
Quality System Regulation (US FDA); ISO 13485 certification: vendor quality systems; quality audit requirements; customizing a Quality Management System to the size of the company; QSR vs. ISO 13485; QMS audits by regulatory authorities and/or conformity assessment bodies
Device Design and Development Process
Some aspects related to risk already assigned.
Design controls; Failure Mode and Effects Analysis; product technical file-how is it created during product development, what does it include and how it is used in premarketing application submissions; regulatory requirements for medical device quality management systems (QMS) in pre- and postmarketing phases (including design controls); assessment of human factors in medical device design and use; evaluation and risk management of medical device software
Labels, labeling and instructions for use of medical devices, including electronic formats
Design transfer; verification and validation; production for clinical trials vs. final product; regulatory requirements for sterilization of medical devices; packaging
Is a clinical trial necessary; device trial design; human subjects protection, ethical considerations and informed consent; Good Clinical Practice requirements (ISO 14155 and US FDA); pre-trial notifications ex-US and US IDE submission-IDE or no IDE; using CROs; clinical trial planning/monitoring-adult vs. pediatric; clinical development plan; difference between device and drug trials; ensuring compliance with regulatory requirements for clinical trials; what clinical evidence and evaluation are required as part of premarket assessment of conformity with regulatory requirements
What are the most important characteristics of in vitro diagnostic medical devices (IVDs) that distinguish them from other categories of medical devices for regulatory purposes? Are there "borderline" issues to be borne in mind when developing regulatory strategies? How are IVDs regulated in different countries (e.g., as medical devices, as pharmaceuticals, or as a unique category)? Are there regulatory strategies specific to IVDs? How do clinical evidence requirements differ between IVDs and other medical devices and what does that mean for clinical evaluation strategies? To what extent do the clinical evaluation, clinical evidence and conformity assessment requirements take into account genetic, gender, ethnic and other differences between and within populations? What are the considerations for standalone IVDs and those that require instrumentation? What considerations are needed for point-of-care and home-use assays?
Global Regulatory Processes
US-PMA vs. 510(k); EU; Canada; Asia and Pacific Rim (including Australia and New Zealand, ASEAN); South and Central America; other countries (e.g., Saudi Arabia, India, South Africa); applicable regulations, guidance, resources and precedents; risk-based classification of medical devices by region-how is a medical device classified under different regulatory systems?; registration of manufacturers, importers and distributors and listing of medical devices; environmental protection regulatory requirements for medical devices
How may the manufacturer use conformity with voluntary standards to demonstrate conformity with regulatory requirements? What are the different kinds of standards? On what basis, and for what purposes, are standards "recognized" by regulatory authorities? How can a manufacturer use conformity with standards to demonstrate a device is consistent with the generally recognized "state of the art" for regulatory purposes? How can manufacturers, academics, regulators and other interested parties participate in the development of standards? What standards generally are most useful for demonstrating the medical device safety and effectiveness? What are the differences between product standards and process or system standards, and how are they used? Where can the appropriate standards be found?
Labeling; claims; indications/intended use(s); physician payments open transparency rules; advertising: print and web; balance between pre- and postmarketing regulatory control
Requirements; studies; technical support; complaints; continuous improvement (and links to the QMS corrective and preventive action systems); sponsored research; medical device postmarketing surveillance and adverse event/vigilance reporting; medical device field safety corrective actions (e.g., recalls and advisories)
What are the profiles of regulatory professionals required in industry and regulatory authorities? What professional skills are needed to bring a new medical device to market and fulfill all post-marketing regulatory requirements? Where can appropriate regulatory information across all geographic areas and venues be found? What electronic databases are available and how can they be employed? What are the key online resources of country-to-country regulatory agencies