Regulatory Essentials in Health Tech

The Regulatory Essentials in Health Tech training series consists of 14 on-demand webinar sessions (1.5 to 2 hours each). The sessions cover all stages, from the birth of a medical device or in vitro diagnostic innovation to market access and post-market surveillance. The first four sessions form the core of the training for any health tech developer and stakeholder, from innovators to investors. The rest of the sessions are designed to deepen knowledge by providing real-world examples from the title areas. Dedicated sessions for medical device software and in vitro diagnostics (IVD) are included.

Price: 1900 € for the entire training series of 14 on-demand sessions. Three or more attendees from the same organization are entitled to a 20% reduction for the entire training series. Incubators, regional business units, universities, and other institutions may request unlimited access for their start-ups or researcher teams, students, and staff for 7500 €/year (prices are excluding VAT). Contact academy@aurevia.com for group discounts and institutional registrations.

The training series includes the following sessions:

• Compliance as a Business Advantage: This session provides an overview of how to align compliance with your business, marketing and sales needs. Learn about medical device regulations and standards and how to use them as your competitive advantage.

• Early Development and Management: This session wraps up the must-know issues to consider in the early development of your innovation, including how to demonstrate compliance with applicable regulations and build up a Quality Management System (QMS) that ensures that devices consistently meet the requirements for safety and performance.
  
  
• The Core of the Regulatory Requirements: This session introduces the General Safety and Performance Requirements, which are the heart of the regulation. It explains the principles of clinical evaluation and risk management for medical devices, both essential for fulfilling the manufacturer’s obligations.
  
  
• Design Control and the Regulatory Environment: This session reviews the principles of design control, starting from feasibility studies to post-market surveillance. A brief look at the roles of the key authorities, certifiers, and test laboratories overseeing devices and manufacturers is also given.
  
  
• Regulatory Essentials of In Vitro Diagnostics: This session is dedicated to essentials for IVD developers, presenting the most critical IVD standards, IVD risk classes, and regulatory strategies for market entry. Some other IVD specifics are also presented, such as compiling General Safety and Performance Requirements for IVDs and performance evaluations. 
  
  
• Medical Device Software: This session is dedicated to medical device software, presenting the essentials of software qualification and classification from both the EU and US perspectives. The most relevant standards, IEC 62304 and IEC 82304, for software life cycle requirements are introduced, and topics such as artificial intelligence (AI) and cybersecurity are discussed. 
  
  
• Risk Management in Practice: This session provides a practical approach to implementing risk management according to the ISO 14971:2019 standard. Stages of risk management and evaluation principles are presented. 
  
  
• FDA: This session gives a basic understanding of the US regulations for medical and in vitro diagnostic devices. The regulatory path to the US market and essential items related to the US Food and Drug Administration are reviewed. 
  
  
• Usability and Labelling: This session introduces the essentials for usability and labelling. Usability standard IEC 62366, user interface and human factors are explained. The session includes also a compact briefing of essential labelling such as instructions for use, use of symbols and marketing claims. 
  
  
• Biological and Electrical Safety: This session presents the core requirements for demonstrating biological and electromedical safety for medical devices. The ISO 10993 series of standards are reviewed, from material characterization to biocompatibility testing. Likewise, the IEC 60601 and its application for determining electrical safety is presented. 
  
  
• Clinical Evaluation in Practice: This session presents the essentials of clinical evaluation, including the requirements and guidelines for clinical evaluation and the structure of the clinical evaluation plan and report. From the perspective of in vitro diagnostics, performance evaluation is also reviewed. Clinical evaluation for medical device software is also briefed, as well as conducting a literature report.
  
  
• Clinical Investigations in Practice: This session covers how to conduct a well-designed clinical investigation to produce data on the safety and performance of a medical device. Clinical investigation planning should be part of the early development of a medical device to best comply with the requirements. Practical considerations related to clinical investigations are summarized in this session. 
  
  
• Post-Market Surveillance and Clinical Follow-up: This session gives a basic understanding of the regulation of Post-Market Surveillance (PMS) and the mandatory PMS documentation, such as the Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP). 
  
  
• Person Responsible for Regulatory Compliance: This session summarizes the most important elements for a Person Responsible for Regulatory Compliance (PRRC) to consider when carrying out their tasks. Obligations of economic operators, management responsibilities and essential processes for continuous improvement of quality management are revised. This session covers items that are additional to the previous sessions of the training series and completes the qualification for employees assigned with the responsibilities of a PRRC.