In the medical device approval process, many companies repeatedly encounter the same obstacle: the correct handling of measurable parameters in Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). Notified bodies require precise, measurable, and substantiated claims.

Objective of the workshop:

This interactive workshop aims to provide participants with the necessary knowledge and tools to:

• Identifying measurable parameters for your product: Learn which measurable parameters are crucial for the approval of your medical device and how to effectively highlight them in your documentation.

• To develop effective and precise formulations: Develop strategies to formulate your claims clearly, precisely and convincingly.

• To perform a correct assessment: Understand the methods and processes necessary to correctly assess and interpret your data.

• To carry out a successful substantiation: Learn how to substantiate your claims with solid data and evidence, thus meeting the requirements of the Notified Bodies.

Who is this workshop suitable for?

This workshop is specifically designed for professionals from the medical device industry who are directly or indirectly involved in the approval and clinical evaluation of medical devices.

The workshop is also of interest to managing directors and decision-makers within start-ups and established companies in the medical device sector. They can gain a deeper understanding of the regulatory requirements, which improves the strategic planning and time-to-market of their products.

This interactive workshop focuses on the role of the sponsor in clinical trials with medical devices. Participants will gain detailed insights into:

• Sponsor's responsibilities: Learn more about the key tasks and how they can be implemented effectively.

• Responsibilities: Understand the legal and ethical obligations that come with the role of sponsor.

• Responsibilities: Explore the sponsor's areas of responsibility and how successful monitoring and control of clinical trials can be ensured.

Who is this workshop suitable for?

This workshop is aimed at professionals in the medical device industry, particularly those involved in the development, approval, and monitoring of medical devices. Whether you work in quality assurance, regulatory affairs, or clinical research, this workshop will provide you with valuable insights and skills to navigate the approval processes efficiently and successfully.

The role of the Person Responsible for Regulatory Compliance (PRRC) is a key position within the medical device industry, established by the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This function bears central responsibility for ensuring that a company's products comply with applicable regulatory requirements. Our workshop aims to provide participants with a thorough understanding of the tasks, duties, and documentation requirements of the PRRC role.

This workshop provides you with the necessary knowledge and practical tools to:

• Understanding the PRRC's responsibilities: Gain a comprehensive overview of the responsibilities associated with the PRRC role, including monitoring compliance with regulatory requirements and ensuring that conformity assessment procedures are carried out properly.

• Fulfillment and documentation of tasks: Learn how to effectively fulfill the tasks of the PRRC and appropriately document the relevant activities and decisions to meet regulatory requirements.

Who is this workshop suitable for?

The workshop is aimed at a broad target group within the medical device industry, including:

• Future and current PRRCs

• Regulatory Affairs professionals

• Quality management team members

• Managing directors and executives

Implementing an effective quality management system (QMS) according to ISO 13485 and the Medical Device Regulation (MDR) is mandatory for all medical device manufacturers. Our workshop provides detailed insights and practical guidance on how to establish an audit-proof QMS that not only meets regulatory requirements but also improves your company's efficiency and product quality.

The workshop teaches participants:

• Insight into the requirements of ISO 13485 and MDR: Gain an in-depth understanding of the specific requirements of both regulations for the quality management system.

• Building an audit-proof QMS: Learn how to build a QMS that meets audit requirements while improving your company's operational efficiency.

• Identifying and closing gaps: We will show you methods to identify existing gaps in your QMS and to take effective measures to close them.

• Best practices and case studies: Benefit from best practices and learn from the experiences of other companies.

Who is this workshop suitable for?

This workshop is aimed at a wide range of professionals in the medical device industry, including:

• Quality Management Representative

• Regulatory Affairs Manager

• Managing directors and executives

A thorough literature search is a crucial step in the clinical evaluation of medical devices, forming the basis for a sound assessment of your product's safety and performance. This workshop serves as a practical complement to our e-learning offerings and focuses on specific exercises and techniques tailored to your product. Experience interactive practical exercises that will not only provide you with the necessary knowledge but also enable you to apply it in real-world situations.

Workshop participants will learn:

• Efficient literature search strategies: Develop skills to efficiently and effectively search for relevant literature for the clinical evaluation of your product.

• Literature review and selection: Learn how to review and select the literature you find and determine its relevance to the clinical evaluation of your product.

• Practical application to your product: Conducting literature searches using real-world examples specifically tailored to your product in order to immediately apply the learned techniques.

• Documentation and Reporting: Understand how the results of the literature search are documented and integrated into the clinical evaluation report to meet regulatory requirements.

Who is this workshop suitable for?

This workshop is ideal for anyone working in the field of Regulatory Affairs or Clinical Affairs for medical devices.

In the fast-paced world of the medical device industry, continuous compliance with regulatory requirements is crucial for market success and patient safety. Our "Regulatory Update" workshop focuses on the critical importance of gap analysis in this process. The goal is to empower companies to keep their technical documentation up-to-date and ensure regulatory compliance.

Participants in this workshop will:

• Develop an understanding of regulatory changes: Gain an overview of the latest regulatory developments and changes in the medical device industry, particularly with regard to ISO 13485, MDR and other relevant standards.

• Learn the basics and implementation of gap analysis: Learn the methodology of gap analysis to effectively identify discrepancies between current regulatory requirements and the current state of your technical documentation.

• Develop action plans to close gaps: Develop skills to create and implement targeted action plans to close identified gaps based on the results of the gap analysis.

• Discover best practices for maintaining compliance: Learn how to implement a continuous monitoring and updating system for your technical documentation to ensure ongoing regulatory compliance.

Who is this workshop suitable for?

This workshop is aimed particularly at all PRRC and Regulatory Affairs Managers.

Digitalization in healthcare is transforming how medical services are offered and received. From electronic health records to telemedicine services, digitalization offers tremendous opportunities to improve patient care, increase efficiency, and reduce costs. This seminar/webinar highlights the many benefits of digitalization in healthcare while also addressing the challenges and risks associated with the implementation of digital technologies.

Participants of this seminar/webinar will:

• Understanding the benefits of digitalization: Learn how digital technologies increase efficiency, improve patient care, and create new opportunities for healthcare providers.

• Recognizing opportunities: Identify the opportunities that digitalization offers your company and learn how to use them effectively.

• Managing risks and challenges: Understand the potential risks and challenges of digitalization, including data privacy concerns and security risks, and develop strategies to manage them.

• Strategies for successful implementation: Develop strategies for the successful introduction and use of digital technologies in your organization.

Who is this seminar/webinar suitable for?

The seminar/webinar is aimed at a broad target group within the healthcare sector, including:

• CEOs and executives of healthcare institutions: decision-makers who determine the direction of their organization in the digital age.

• DiGA manufacturer

• IT managers in healthcare: Professionals responsible for the development, implementation, and management of digital technologies.

• Medical professionals: Doctors, nurses and other healthcare professionals who use digital tools in their daily work.

• Regulatory Affairs and PRRC Officers: Professionals who ensure that digital solutions comply with legal requirements.

Digital health applications (DiGA) are revolutionizing medical care by providing patients and physicians with innovative tools that support treatments, complement therapies, and improve preventative healthcare. Our seminars offer both patients and physicians the opportunity to gain in-depth insights into the world of DiGA, understand its potential, and optimize its use in everyday clinical practice.

Seminar for patients

Our seminar for patients provides a comprehensive understanding of digital health applications (DiGA) that goes beyond the basics and specifically addresses concerns regarding the doctor-patient relationship. The aim is not only to educate patients about DiGA, but also to clarify how these tools can support and complement the therapeutic relationship, rather than replacing it.

Participants in this seminar will:

• Gain a basic understanding of DiGA: Learn what digital health applications are, how they are classified, and what regulatory standards they must meet.

• Get information about DiGA: Gain insight into the availability, access and correct use of DiGA as well as information about security and data protection.

• Assess the relevance of DiGA: Learn how DiGA can support and complement healthcare, and understand its value as part of your health plan.

• Understanding how DiGA can complement the doctor-patient relationship: Learn how DiGA can improve communication and interaction with your doctor and support the therapeutic relationship without replacing it.

Who is this seminar suitable for?

Patients and their relatives who are interested in the integration of digital technologies into their healthcare and have concerns about the digital transformation in healthcare.

Seminar for doctors

This seminar aims to provide physicians with a time-efficient overview of the topic of Digital Health Applications (DiGA). It focuses on the following key topics:

• Gain an overview of DiGA in healthcare: Deepen your understanding of the role of DiGA in modern medicine and its potential to improve patient care.

• Effective patient education: Develop strategies to inform patients about DiGA efficiently and understandably, including its applications, benefits, and safety.

• Integrating DiGA into practice: Learn how DiGA can be seamlessly integrated into everyday practice and use digital tools to increase treatment efficiency.

• Billing and reimbursement of DiGA: Receive detailed information on the billing and reimbursement of DiGA to optimize financial and administrative processes.

• Assessing the benefit to the patient: Learn to assess and communicate the individual benefits of DiGA for patients in order to promote acceptance and adherence.

Who is this seminar suitable for?

Doctors and medical professionals of all specialties who wish to use DiGA in their practice.

Practice managers and administrative staff involved in the billing and management processes of DiGA.