• Medical Technology
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Audits

Product group

Audits are an independent, systematic method for determining whether systems meet requirements and processes are designed to be low-risk from the customer's perspective. Audit criteria can be standards such as ISO9001, ISO14001 or ISO5001 or industry-specific supplements such as IATF 16949, VDA 6.3, CQI14, CPA. Our partners can help you here with the qualification of your employees as auditors, with or without a certificate, e.g. according to ISO17024. You can also offer your company the necessary support yourself through 1st/2nd or 3rd Party Audits, in order to manage your systems and suppliers conform and economically.

VDA 6.3, ISO9001, ISO Standards, IATF 16949, VDA Standards

Consulting and Extended Problem-Solving II

Are you facing a major restructuring? Are you looking for ways to fundamentally improve yourself and your company?We as external consultants offer a new and fresh perspective directly out of a Start-Up Environment!   Taliox Who are we? We are a successful start-up from Hamburg that offers a variety of services in the field of information technology. Taliox was founded in 2016 by four IT specialists and has since been helping its customers to benefit from innovative and state-of-the-art technologies. As today's digital natives, our team can deliver innovative software solutions by combining an intrinsic technical understanding with the latest research. As an innovative digitizer, we optimize processes, design digital strategies, and carry out feasibility studies. We realize our customers' ideas, whether it is a web or desktop application, an app, or a website. Furthermore, with a platform for advanced digital quality planning and an Audit Assistant, we have a constantly expanding product portfolio.   Industry sectorsIT consulting, automotive, consumer goods, software development Areas of applicationproject management, process management, strategy development, concept development, team management, IT security, digitization, software development, performance optimization ProductWe provide organizational consulting, develop information strategies for your company, carry out feasibility studies and calculate the solution costs.With the aim of solving the actual problems directly! Building up on our consulting methods from Problem-Solving and Consulting I we will build a first solution for your problem in this process and test its suitability for you.  We will concentrate on the first three steps of our methodological consulting, based on our experience, will adapt to your needs in this process.  Methods IDEATE  PROTOTYPE TEST Our way of working is divided into three activities according to our consulting work. In the first step, the information shared with us is used to generate and evaluate different ideas based on your challenges. We then switch to prototyping mode after detailed elaboration to create prototypes that will be used for evaluation.The prototype can be very versatile and depends on your ideas. This can range from a web or desktop application, a website to an app! Finally, the prototype that has now been built is used to generate actual user feedback.Instead of working at the concept level, this format is more of a practical type to generate results that might as well be used in future project phases. Companies with whom we can work can break down stuck thinking patterns with our help and make the best future-oriented decisions in intensive cooperation with us. Our working concept effectively structures our cooperation with the aim of your maximum success

Technical Cleanliness, VDA 6.3, Strategy Consulting, Quality Management, Management, Functional Safety, Damage Analysis, ISO Standards, Health Management, Data Security Management, Product Safety, VDA Standards, Project Management, Work Safety Management
taliox
s
Europe
Q
85.00 € Per Hour

IDOS MIC/3 - Simple connection of measuring equipment to SAP QM

SAP ADDON MIC/3:DIRECT CONNECTION OF MEASUREMENT EQUIPMENT TO SAP QMThe measurement equipment interface connector MIC/3 is a cost-effective add-on for direct online measurement value recording via the SAP interface and transaction. MIC/3 allows direct connection of measurement equipment via diff erent interface systems to the SAP QM application and is also incorporated directly into SAP results recording.MIC/3 supports all common interface systems for interface boxes, e.g. Steinwald, Bobe, Mitutoyo, Ibrit, Elias, Brecht, etc.. Alternatively, measurement equipment can be connected directly to the PC easily via the COM/USB interface – in this case, no interface box is required.A free demo version is available.

Quality Management, ISO Standards
Quality Miners GmbH
s
Africa, China, Europe, North America, Oceania, South America, Southeast Asia
Q
4,150.00 €

Implementation DIN EN ISO 13485 - Quality management for medical devices

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 Price per participant open training:               2.600,00 EUR Price per company internal event:                 16.500,00 EUR

Quality Management, ISO Standards
GAB Europe

Implementation DIN EN ISO 13485 - Quality management for medical devices

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.

Quality Management, ISO Standards
GAB Europe
s
Europe
Q
3,300.00 € Per Day

Problem-Solving and Consulting I

Taliox Who are we? We are a successful start-up from Hamburg that offers a variety of services in the field of information technology. Taliox was founded in 2016 by four IT specialists and has since been helping its customers to benefit from innovative and state-of-the-art technologies. As today's digital natives, our team can deliver innovative software solutions by combining an intrinsic technical understanding with the latest research. As an innovative digitizer, we optimize processes, design digital strategies, and carry out feasibility studies. We realize our customers' ideas, whether it is a web or desktop application, an app, or a website. Furthermore, with a platform for advanced digital quality planning and an Audit Assistant, we have a constantly expanding product portfolio.   Industry sectorsIT consulting, automotive, consumer goods, software development Areas of applicationproject management, process management, strategy development, concept development, team management, IT security, digitization, software development, performance optimization. ProductWe provide organizational consulting, develop information strategies for your company, carry out feasibility studies and calculate the solution costs. Derived from our work process, we focus our consulting service on understanding customer challenges, developing concepts and selecting the best possible solution to remedy identified defects. We will concentrate on the first three steps of our methodological consulting, based on our experience, will adapt to your needs in this process. In addition on focusing on the first three steps of our consulting method, tasks such as analyzing the data of a company, determining the requirements for the information system, submitting software and hardware recommendations, defining project objectives, compiling and presenting information are the cornerstone of our Way of working.  Methods EMPATHIZE DEFINE  IDEATE Understanding you, the first activity, is the fundamental step to approach your problem and put ourselves in your situation.We use systematic interviews, observations, and the information you share. In the second phase, your needs are further narrowed down and defined by techniques such as a Stakeholder map, the desk research method, ... In the end we get a clear picture of your current situation. The idea phase then serves to generate radical and alternative solutions.This phase is the most dynamic process of our advice and at the same time the most exciting for you.Experience shows that everything comes together here and results in well thought-out solutions.You can benefit the most from this phase. Participants in this consultation can use the full potential of our company in a short period of time and use it for themselves. We offer you, free of our own interests, to analyze your problems and to develop solutions together with you.Participants in this consultation open new perspectives, elegant solutions, and lucrative business ideas.

Technical Cleanliness, VDA 6.3, Strategy Consulting, Quality Management, Management, Functional Safety, Damage Analysis, ISO Standards, IRIS Standards, IATF 16949, Health Management, VDA Standards, Project Management, Work Safety Management, Human Performance
taliox
s
Europe
Q
85.00 € Per Hour

quiub® as integrated management system

The SaaS-solution for your strategically optimal management system It often proves to be extremely complex for companies to integrate their own corporate cultures into their management system. The two-world principle: management and business issues against processes, procedures and operational systems come together. The future-oriented successor of management software solutions is called quiub®. - suitable for all industries. For small, medium and large companies. Different systems and regulations can be controlled in a complementary way with the quiub®. With your quiub® you can integrate ISO 9001, ISO 14001, ISO 13485 and IAFT 16949 or even completely different sets of rules and regulations into a single system as required. In this way, Quiub® enables you to collect and process various parallel systems centrally in your company. With quiub®, you can immediately see whether your company meets the requirements of the applicable standards, and you can take immediate action in case of non-compliance. All information is available in quiub® and can be accessed from anywhere at any time. Advantages and functionalities of the quiub® software for integrated management systems All project management and quality management functionalities are included in quiub® IMS All standards, laws and directives according to uniform field of application Development and expansion of your integrated management systems Coordination of the various management systems International use thanks to innovative multilingual concept Transparent mapping organisational structures with several locations Browser-based, web-based solution for mobile content An integrated management system always makes sense if parallel management systems are maintained in a company - whether it is "only" quality management and environmental protection or occupational health and safety. At the latest then an integrated system should be considered more closely if another system is to be added. As parallel systems often lead to redundant data maintenance, higher and interface problems. The essential things become simple. With quiub® you can map all your rules and regulations in one application. Transparency is the key to success A further highlight is the Saas solution, which allows all employees to use the fields of activity and processes licence-free. It also offers direct and uncomplicated access to information, documents and reports. With quiub® as the basis for an integrated management system, numerous interfaces and links are possible. If you are interested in a complete overview of compatible systems with quiub or an individual constellation analysis, our experienced technical consultant is always available to help you. How big should your integrated management system be? quiub® software is exactly the size you need. Were we able to arouse your interest? Do you have any questions? Then please contact us directly or simply make an appointment for a live demo.

Agile Organizations, Strategy Consulting, Quality Management, Management, Environmental Management, ISO9001, ISO Standards, Health Management
Decura Quiub GmbH
s
Europe
Q
4,900.00 €

Supply Chain Act (Act on Corporate Due Diligence in Supply Chains)

Supply Chain Act (Act on Corporate Due Diligence in Supply Chains)   The Act on Corporate Due Diligence in Supply Chains, also known as the Supply Chain Act or Due Diligence Act was published in 2021. In simplified terms, this will require companies selling products in Germany to end customers to demonstrate that they themselves and their supply chain respect and comply with basic human rights, as applicable to business contexts. The aim of the law is to regulate corporate responsibility for the observance of human rights in relation to all products manufactured and sold in Germany. Companies must provide proof of compliance to authorities or organizations that have yet to be defined. From 2023, there will be heavy financial penalties if it can be proven that the underlying obligations have not been met. However, the idea of the law is not just to create more reports and increase bureaucracy, but for companies to actively deal with the issues and process them in a formative way.   We see this as a standard management function of every company and not as a fundamentally new requirement. Many companies have already anchored compliance and sustainability requirements in their supply chains on a voluntary basis. All modern management systems of companies must be oriented to the context of the organization and be designed in such a way that changes in e.g. legal requirements and expectations can also be incorporated. Risk management and due diligence with regard to economic and legal risks and in the event of non-compliance with customer expectations is daily practice. Here, risk management only needs to be extended to include sustainability aspects if it has not already been implemented anyway. Of course, all of this must be anchored in the company's value system by top management.   In this event, we want to give you impulses on how to evaluate and expand your existing management system in order to incorporate the requirements of the Supply Chain Act without having to set up completely new systems. The two perspectives - manufacturer and supplier - will be considered separately. The solution must be designed in such a way that, embedded in a comprehensive sustainability strategy, it contains the necessary processes and methods to be able to map the requirements of the Supply Chain Act but also other requirements and expectations of the market with regard to all fields of sustainability. Just buying a reporting software is certainly too little, redoing everything is certainly too much. Let us show you a pragmatic way.   Contents: -        Existing regulations on sustainable corporate governance (UN Global Compact, ISO 26000, SA8000 etc.) -        Classification of the Supply Chain Act -        Assessment and reporting systems (GRI, audit, CSR, SRI, ESG indices, EU taxonomy guideline, NFRD, CSRD etc.) -        Grievance systems -        Role and tasks of the manufacturer -        Role and tasks of the supplier -        Alignment with existing management system requirements (ISO9001, ISO 14001, OSHAS) -        Essential processes and methods to complement the existing system -        Procedure (Evaluate - Report - Observe) -        Global supply chain assurance (self-reporting expert assessment) -        Outlook Duration: 2h online with 15min break after 1h Type: Virtual Classroom Prerequisites: none Note: the participant is responsible for the technical equipment of the participant's workplace. You need a computer with an up-to-date Internet browser that is capable of Chrome, i.e. Google Chrome, Microsoft Edge Chromium or the current Firefox. There should be sufficient bandwidth on the part of the participant. A camera is not required, a good audio system (speakers and microphone) is required. Proof: attendance certificate

Management, Environmental Management, ISO9001, ISO Standards, Energy Management, COSAX, Work Safety Management, Sustainability, Supply Chain Act, Law on Corporate Due Diligence in Supply Chains, EU Taxonomy Regulation, SRI, CSR, GRI, ESG, Due Dilligence
MDQM
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