Introduction: The purpose of quality management is to create trust for the customer in the performance of a company. This trust is of particular importance when medical products are involved and consumers rely on the effectiveness of the medical products. Acquire competence in the implementation of quality management for medical devices and comprehensive knowledge of the requirements of the standard DIN EN ISO 13485:2016. Through clear practical examples and exercises, you will learn about the special focuses, legal and regulatory requirements and advantages that this standard offers your company. Trainer competence: Several years of experience in the production of medical devices and projects for the implementation of DIN EN ISO 13485 in companies distinguish our trainers for this seminar. Goal: Participants understand the specific requirements of DIN EN ISO 13485:2016 and are able to implement them successfully in their company. Content: o   Sense, purpose and advantages of quality management for medical devices -       Requirements of interested parties o   Identification of legal and regulatory framework conditions -       European directives and medical devices law -       Risk management according to DIN EN ISO 14971 ·   Requirements for risk management and market monitoring ·   Required documented information -       Placing medical devices on the market -       Medical Device Safety Plan Ordinance o   Requirements and implementation of a quality management for medical devices according to DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015 o   Conformity assessment and declaration o   Duties, rights and cooperation with consultants and security officers o   Market monitoring and reporting system o   Control of the processes by means of key figures o   Organization of audit activities in the quality management system for medical devices o   Evaluation of the effectiveness of the quality management system o   Competence check or final examination Requirements: none Target group: Persons and managers who are involved in the production of medical devices and who want to introduce and implement a quality management system. Duration: 5 days Literature: Seminar documents and relevant legal texts   The price does not include travel cost such as hotel, flight etc. for the trainer. The cost for rooms and catering during the inhouse event will be carried by the client.

Audit procedure for the identification of insecure and risky system components The security of infrastructures and IT systems requires an appropriate use of cryptography and security tools. A wrong use or faulty instantiations often have a tremendous impact on the security of complete IT infrastructures. They represent the gateway for attackers and malware. Quantum computers represent an advancing technology that break all currently applied public key cryptosystems. The security is threatened to an unprecedented extent. Resulting financial losses and reputational damages due to lack of prevention and appropriate protection measures may affect the situation of the company in the short and long term. Due to the complexity of software applications and IT systems, it is important to check and monitor the security of the system in terms of the correct use of cryptographic algorithms and tools. It is therefore important to have the right protection measures in place. To this end, the security system has to be assessed with respect to compliance with the security requirements. In a first step, the security requirements have to be determined. Subsequently, the security of the system under consideration is screened and checked in order to identify risky and insecure components that do not satisfy the requirements. This also includes the correct usage of crypto libraries, crypto functions and other tools. Furthermore, components that are vulnerable to quantum computer attacks are separately identified. The various parts then have to be assessed according to their risk and will be classified into different risk classes.  In the next stage, the conception of an appropriate IT security strategy is carried out. It contains an action plan and roadmap that transforms the IT infrastructure into the desired shape ensuring the desired security goals while being protected against any quantum computer attacks. Immediate action requests can be addressed using the solutions provided by QuantiCor Security. This holistic approach allows to capture individual circumstances and to treat them in a very targeted manner. Is your company also immune against threats arising from new technologies? In our analysis and consulting services, we take all kinds of threats into account. These also include those arising from new technologies and innovations, such as quantum computers. We take special care to recommendations of BSI (Federal Office for Information Security) and NIST. After a positive evaluation of your systems, it is possible to obtain a TÜV-label that is issued in cooperation with TÜV Nord. Beside other benefits it demonstrates quantum computer resistance of your systems to your customers.    You want to… learn more about the risk posed by quantum computers? determine your security level and your current need for action? Let's do the quick check: Initial consultation Individual questionnaire, analysis and evaluation Concrete recommendations for action  About QuantiCor Security QuantiCor Security is an IT security partner and expert for the security risk of quantum computers and multi-party computation. We are part of the innovation cluster for cyber security and support companies from all industries with resource-saving and future-proof solutions (incl. OTA updates). Our approach: Analysis, technology development, product integration and support. With pleasure we support you as: -Project partner and consultant-Technology developer-Provider for quantum-safe software solutions Lets increase your security level together!  

Our joint challenge The current situation is a great challenge for everyone, and more than ever before, you need to be focused and professional in order to stay confident and powerful during this time and to ensure that team work runs smoothly.Many managers are particularly in demand in this situation and at the same time are faced with the question for the first time: How does virtual leadership work?For this reason, managers should be supported and accompanied by a suitable virtual format to meet this challenge.This will be presented in the following: a modular online practical training with coaching for executives to accompany and support them in the currently unplanned situation - and beyond. Module 1 Me: Personal in spite of distance My role and attitude (the new learning mode, leaving the comfort zone of the familiar, confidence and radiance, me as a crisis manager, dealing with mistakes) My action (how do I appear as a digital leader? How do I show leadership? clarity and transparency) Self-organisation, self-management (work rhythm, breaks, personal energy sources), creating a virtual working environment (auditory, visual), demarcation in the home office My own reporting to the organization (supervisors, peers, employees, customers, stakeholders) Number of participants (max. 6), no fixed learning group. Number of appointments (1.5 h per session) that do not build on each otherEach of the 4 modules can be booked for each of the 6 time slot 07:00-08:30 Early Birds09:00-10:30 Morning Smarty12:00-13:30 Lunch & Learn15:00-16:30 Tea Timer17:00-18:30 After Work Smarty21:00-22:30 Night Liner Central European Time, CET Our Virtual Classroom is browser-based, so that participants receive an access link with their invitation, which allows them to easily dial in without installing plug-ins or an app.Nevertheless, a connection check in advance is recommended to ensure good communication between your IT and our platform. On request, connection checks with each participant in advance Preparation and realization per Smarty (1,5 h) incl. participant documents as PDF€ 600,00 (up to 6 participants) Technology check and provision of the Virtual Classroom€ 15,00 per participant Presentation "Leadership Smarties"on YouTube https://www.youtube.com/watch?v=ESzHEtxENfs Overview of modules: Module 1 Me: Personal in spite of distance Module 2 Me + You: Creating affiliation and commitment Module 3 I + MY TEAM: Providing for efficient exchange Module 4 ME + THE ORGANISATION: Participation & Communication  

Our joint challenge The current situation is a great challenge for everyone, and more than ever before, you need to be focused and professional in order to stay confident and powerful during this time and to ensure that team work runs smoothly.Many managers are particularly in demand in this situation and at the same time are faced with the question for the first time: How does virtual leadership work?For this reason, managers should be supported and accompanied by a suitable virtual format to meet this challenge.This will be presented in the following: a modular online practical training with coaching for executives to accompany and support them in the currently unplanned situation - and beyond. Module 2 Me + You: Creating affiliation and commitment How can I build a personal relationship with my employees online (key questions, relationship-building rituals, creating a culture of trust, virtual time management)? communication rules, develop a feeling for "nuances" Feedback (online feedback, how does it work? from criticism to celebration of success) Challenge and support from a distance (delegate digitally, agree on goals, establish commitment, secure results, tie up work packages online, develop strengths from a distance) Motivation in the virtual team Number of participants (max. 6), no fixed learning group. Number of appointments (1.5 h per session) that do not build on each otherEach of the 4 modules can be booked for each of the 6 time slot 07:00-08:30 Early Birds09:00-10:30 Morning Smarty12:00-13:30 Lunch & Learn15:00-16:30 Tea Timer17:00-18:30 After Work Smarty21:00-22:30 Night Liner Central European Time, CET Our Virtual Classroom is browser-based, so that participants receive an access link with their invitation, which allows them to easily dial in without installing plug-ins or an app.Nevertheless, a connection check in advance is recommended to ensure good communication between your IT and our platform. On request, connection checks with each participant in advance Preparation and realization per Smarty (1,5 h) incl. participant documents as PDF€ 600,00 (up to 6 participants) Technology check and provision of the Virtual Classroom€ 15,00 per participant   Presentation "Leadership Smarties"on YouTube https://www.youtube.com/watch?v=ESzHEtxENfs Overview of modules: Module 1 Me: Personal in spite of distance Module 2 Me + You: Creating affiliation and commitment Module 3 I + MY TEAM: Providing for efficient exchange Module 4 ME + THE ORGANISATION: Participation & Communication

Our joint challenge The current situation is a great challenge for everyone, and more than ever before, you need to be focused and professional in order to stay confident and powerful during this time and to ensure that team work runs smoothly.Many managers are particularly in demand in this situation and at the same time are faced with the question for the first time: How does virtual leadership work?For this reason, managers should be supported and accompanied by a suitable virtual format to meet this challenge.This will be presented in the following: a modular online practical training with coaching for executives to accompany and support them in the currently unplanned situation - and beyond. Module 3 I + MY TEAM: Providing for efficient exchange Roles and responsibilities in the team New communication formats (touchpoints, dailys, weeklys, huddles etc.) Which media for what? Transparency about work progress and results in the team Bringing about decisions within the team conflict management Cooperation and motivation Number of participants (max. 6), no fixed learning group. Number of appointments (1.5 h per session) that do not build on each other.Each of the 4 modules can be booked for each of the 6 time slot 07:00-08:30 Early Birds09:00-10:30 Morning Smarty12:00-13:30 Lunch & Learn15:00-16:30 Tea Timer17:00-18:30 After Work Smarty21:00-22:30 Night Liner Central European Time, CET Our Virtual Classroom is browser-based, so that participants receive an access link with their invitation, which allows them to easily dial in without installing plug-ins or an app.Nevertheless, a connection check in advance is recommended to ensure good communication between your IT and our platform. On request, connection checks with each participant in advance Preparation and realization per Smarty (1,5 h) incl. participant documents as PDF€ 600,00 (up to 6 participants) Technology check and provision of the Virtual Classroom€ 15,00 per participant Presentation "Leadership Smarties" on YouTube https://www.youtube.com/watch?v=ESzHEtxENfs Overview of modules: Module 1 Me: Personal in spite of distance Module 2 Me + You: Creating affiliation and commitment Module 3 I + MY TEAM: Providing for efficient exchange Module 4 ME + THE ORGANISATION: Participation & Communication

Our joint challenge The current situation is a great challenge for everyone, and more than ever before, you need to be focused and professional in order to stay confident and powerful during this time and to ensure that team work runs smoothly.Many managers are particularly in demand in this situation and at the same time are faced with the question for the first time: How does virtual leadership work?For this reason, managers should be supported and accompanied by a suitable virtual format to meet this challenge.This will be presented in the following: a modular online practical training with coaching for executives to accompany and support them in the currently unplanned situation - and beyond. Module 4 ME + THE ORGANISATION: Participation & Communication My own communication in the organization (superiors, peers, customers, stakeholders) Strengthen team and cross-departmental cooperation, get out of the silos Our positioning in the organization Maintain and expand my network in the company, now virtualLooking beyond the crisis: our contributions to the future of the company (under the current conditions of virtual communication) Continue change processes virtually Number of participants (max. 6), no fixed learning group. Number of appointments (1.5 h per session) that do not build on each other.Each of the 4 modules can be booked for each of the 6 time slot 07:00-08:30 Early Birds09:00-10:30 Morning Smarty12:00-13:30 Lunch & Learn15:00-16:30 Tea Timer17:00-18:30 After Work Smarty21:00-22:30 Night Liner Central European Time, CET Our Virtual Classroom is browser-based, so that participants receive an access link with their invitation, which allows them to easily dial in without installing plug-ins or an app.Nevertheless, a connection check in advance is recommended to ensure good communication between your IT and our platform. On request, connection checks with each participant in advance Preparation and realization per Smarty (1,5 h) incl. participant documents as PDF€ 600,00 (up to 6 participants) Technology check and provision of the Virtual Classroom€ 15,00 per participant Presentation "Leadership Smarties" on YouTube https://www.youtube.com/watch?v=ESzHEtxENfs Overview of modules: Module 1 Me: Personal in spite of distance Module 2 Me + You: Creating affiliation and commitment Module 3 I + MY TEAM: Providing for efficient exchange Module 4 ME + THE ORGANISATION: Participation & Communication

From September 1st, 2020, the new framework regulation (EU) 2018/858 is mandatory for the approval of vehicle types and their equipment. Of course, all training courses from Mark Haacke Training & Consulting are based on the new requirements. The training almost summarizes the essential main points of the basics of the approval procedures and conformity of production and puts them together in a correspondingly focused way for the decision-makers in the companies. Mark Haacke, who can draw on almost 20 years of practical experience in this complex subject area, leads through the training. Do not bother to read legal texts and regulations or directives! Deal directly with the actions to be derived from them! Mark Haacke guides you in a relaxed, eloquent and practical manner through the individual elements of the training and gives you sufficient space for discussions and questions. The aim of the training is to support the management of the companies in the optimal implementation of the obligations, with clear knowledge of the rights, and to be able to define possible measures in the organization.

From September 1st, 2020, the new framework regulation (EU) 2018/858 is mandatory for the approval of vehicle types and their equipment. Of course, all training courses from Mark Haacke Training & Consulting are based on the new requirements. About: The training almost summarizes the essential main points of the basics of the approval procedures and conformity of production and puts them together in a correspondingly focused way for the decision-makers in the companies. Mark Haacke, who can draw on almost 20 years of practical experience in this complex subject area, leads through the training. Do not bother to read legal texts and regulations or directives! Deal directly with the actions to be derived from them! Mark Haacke guides you in a relaxed, eloquent and practical manner through the individual elements of the training and gives you sufficient space for discussions and questions. The aim of the training is to support the management of the companies in the optimal implementation of the obligations, with clear knowledge of the rights, and to be able to define possible measures in the organization.

About: The fulfilment of all legal requirements during the development, production and use of vehicles is an important factor for companies to minimize costs and risks, and it is important to find a reasonable balance between the costs incurred in providing all the required evidence and the risks that may arise from deviating from these requirements. With the appropriate knowledge, you will understand how you as a supplier can meet the requirements of OEM and authorities, who may and/or must communicate with the OEM or authorities and which measures can be taken for field and product monitoring. The training includes the following learning units- Summary of CoP and approval procedures- Product groups affected by market surveillance- Measures for active and passive market surveillance- Levels of recalls- Decision matrix- Organization and committees in the companys- Practical exercises and quizzes to consolidate the acquired knowledge- Learning success control

The fulfilment of all legal requirements during the development, production and use of vehicles is an important factor for companies to minimize costs and risks, and it is important to find a reasonable balance between the costs incurred in providing all the required evidence and the risks that may arise from deviating from these requirements. With the appropriate knowledge, you will understand how you as a supplier can meet the requirements of OEM and authorities, who may and/or must communicate with the OEM or authorities and which measures can be taken for field and product monitoring. The training includes the following learning units- Summary of CoP and approval procedures- Product groups affected by market surveillance- Measures for active and passive market surveillance- Levels of recalls- Decision matrix- Organization and committees in the companys- Practical exercises and quizzes to consolidate the acquired knowledge- Learning success control