In the approval process for medical devices, many companies repeatedly stumble over the same obstacle: the correct handling of measurable parameters in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). The Notified Bodies demand precise, measurable and substantiated claims.

Objective of the workshop:

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

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

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

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

• carry out a successful substantiation: Find out how to substantiate your claims with solid data and evidence and thus meet 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 field of medical devices. They can gain a deeper understanding of regulatory requirements, which improves strategic planning and time to market for their products.

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

• Sponsor's tasks: Find out more about the central tasks and how they can be implemented effectively.

• Responsibilities: Understand the legal and ethical responsibilities associated with the role of sponsor.

• Responsibilities: Explore the sponsor's responsibilities and how to ensure successful monitoring and governance of clinical trials.

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 regulatory processes efficiently and successfully.

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

This workshop will provide you with the knowledge and practical tools you need to:

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

• Fulfillment and Documentation of Duties: Learn how to effectively fulfill the PRRC's responsibilities and adequately document related activities and decisions to meet regulatory requirements.

Who is this workshop suitable for?

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

• Future and current PRRCs

• regulatory affairs professionals

• Quality management team members

• Managing Directors and Executives

The implementation of an effective quality management system (QMS) according to ISO 13485 and the Medical Devices Regulation (MDR) is mandatory for all manufacturers of medical devices. In our workshop you will receive detailed insights and practical instructions on how to establish an audit-tested QMS that not only meets regulatory requirements, but also increases your company's efficiency and product quality.

The workshop teaches participants:

• Insight into the requirements of ISO 13485 and MDR: Get a deep understanding of the specific requirements of both sets of regulations for the quality management system.

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

• Identification and closure of gaps: We show you methods to identify existing gaps in your QMS and 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 variety of professionals in the medical device industry, including:

• Quality management representative

• Regulatory Affairs Manager

• Managing Directors and Executives

Carefully conducting a literature search is a critical step in the clinical evaluation of medical devices that forms the basis for an informed assessment of your device's safety and performance. This workshop serves as a practice-oriented addition to our e-learning offering and focuses on specific exercises and techniques tailored to your product. Experience interactive practical exercises that not only give you the necessary knowledge, but also enable practical application.

Workshop participants will learn:

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

• Evaluation and selection of literature: Learn how to evaluate and select the literature found and determine its relevance to the clinical evaluation of your product.

• Practical application to your product: Conduct literature searches using real-world examples specific to your product to immediately apply the techniques learned.

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

Who is this workshop suitable for?

This workshop is ideal for anyone working in the regulatory affairs or clinical affairs area of ​​medical devices.

In the fast-moving 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 aim is to enable companies to keep their technical documentation up to date and to ensure regulatory compliance.

In this workshop participants 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.

• Get to know the basics and implementation of gap analysis: Get to know the methodology of gap analysis in order to effectively identify discrepancies between the current regulatory requirements and the current status of your technical documentation.

• Create 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.

• Learn 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 the way medical services are offered and received. From electronic health records to telemedicine services, digitalization offers enormous opportunities to improve patient care, increase efficiency and reduce costs. This seminar/webinar highlights the diverse benefits of digitalization in healthcare while addressing the challenges and risks associated with the introduction of digital technologies.

Participants in this seminar/webinar will:

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

• Recognize opportunities: Identify the opportunities that digitalization presents for your company and learn how to use them effectively.

• Manage risks and challenges: Understand the potential risks and challenges of digitalization, including 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:

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

• DiGA manufacturer

• Healthcare IT Managers: Professionals responsible for developing, implementing, and managing digital technologies.

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

• Regulatory Affairs and PRRC Officers: Professionals who ensure digital solutions meet legal requirements.

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

Seminar for patients

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

• Get information about DiGA: Get 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 healthcare plan.

• Understanding how DiGA complements the doctor-patient relationship: Get information about 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 families who are interested in integrating digital technologies into their healthcare and have concerns about digital transformation in healthcare.

Seminar for doctors

This seminar is intended to provide doctors with an overview of the topic of DiGA in a time-saving manner. It focuses on the following main topics:

• Get 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 in an efficient and understandable way, including its indications, benefits and safety.

• Integration of DiGA into practice: Find out how DiGA can be smoothly integrated into everyday practice and use digital tools to increase treatment efficiency.

• DiGA billing and reimbursement: Get detailed information about DiGA billing and reimbursement to optimize financial and administrative processes.

• Assessing patient benefits: Learn to evaluate and communicate the individual benefits of DiGA to patients to promote acceptance and adherence.

Who is this seminar suitable for?

Doctors and medical professionals from all disciplines who would like to use DiGA in their practice.

Practice managers and administrative staff involved in DiGA's billing and administrative processes.