As a provider of training services for IVD product regulation, our aim is to equip professionals with in-depth knowledge of the regulatory landscape pertaining to In Vitro Diagnostic (IVD) devices. Our courses are designed to facilitate a comprehensive understanding of the rules and regulations that govern IVD manufacturing and quality. Here is an outline of the training services we offer:
  • Customized Training Programs: We design tailor-made training courses based on your organization's specific IVD product portfolio, target markets, and regulatory requirements, ensuring that the learning experience is directly relevant to your business.
  • Online In-Person Scheduling Options: We offer flexible course delivery options, allowing participants to choose between live online sessions and in-person classes, depending on their preferred learning mode and availability.
  • Qualified teachers: Our faculty consists of experienced professionals with expertise in IVD regulatory affairs, quality assurance, and medical device manufacturing. They have extensive knowledge of international standards, guidelines, and best practices, ensuring that attendees receive up-to-date and accurate information.
  • Interactive Learning Environment: We believe that engaging and interactive teaching methods contribute to effective learning.Our training courses incorporate the latest technology to make your learning easy and accessible.
Our training courses include:
  • 1. ISO 13485:2016 - Medical Devices Quality Management System: This training course will provide you with a solid understanding of the ISO 13485:2016 standard, its requirements, and how to implement and maintain an effective quality management system (QMS) for IVD products.
  • 2. ISO 14971:2019 - Medical Devices Risk Management: This course will teach you the principles of risk management for IVD products, focusing on the requirements of ISO 14971:2019, and will guide you through the process of identifying, assessing, and mitigating risks associated with your IVD products.
  • 3. IVDR (In Vitro Diagnostic Medical Devices Regulation) and ISO Standards: This training will cover the European Union's IVDR requirements and their interplay with relevant ISO standards, ensuring that you have a comprehensive understanding of the regulatory landscape for IVD products in the EU.
Please let us know which courses you are interested in, and we will provide you with further information on registration and pricing. We look forward to supporting your professional development in the IVD industry.
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DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products.
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