Benefit from the knowledge of our experts in a quality management training session
- Trainings on the EU Medical Device Regulations, the Austrian Medical Device Act, and relevant standards
- Extensive know-how from practitioners for practitioners
- Clarification of responsibilities and optimization of internal resources
High demands are placed on medical devices, which require a lot from companies, their management and the testing and quality of the products. Innovations, a flawless quality management and various standards – Before a medical device can be approved, many essential points have to be covered.
We at en.co.tec support you in this process! Through our online seminars and face-to-face seminars, as well as in-house training at your company, you have the opportunity to expand your know-how in the field of quality management and benefit from further training. We come from the practice and prepare you for the practice!
Our range of training courses for quality management
With our expertise in various areas related to medical devices, we can provide you with the best possible advice in quality management and subsequent approval. As practitioners, we specialize in conveying the contents of various standards in the medical device industry to you as simply and comprehensibly as possible.
Through our trainings and courses, we give you an insight into the Medical Device Act and the various European regulations. In addition, responsibility for management and the various areas of responsibility is defined, and the interface with risk management is explained.
We place special focus in all our seminars on how advanced your knowledge of the topic is. The goal of our training courses is to enable you to take quality management in your company into your own hands – we act as your guides on the path to greater quality.
ISO 13485:2016 Basic course
In this practice-oriented ISO 13485 basic course, you will receive all relevant information on the most important standard in medical technology: Clear, with many examples, and individually tailored to your company. Your trainer, DI Martin Schmid, brings experience from various medical technology companies, whom he has supported in implementing ISO 13485 for more than 20 years.
The course content covers various areas of the ISO 13485:2016 standard, giving you a comprehensive overview. You will learn more about quality, management, and testing, and will be able to skillfully apply the acquired know-how in practice.
The following areas are covered in a course:
- Medical Device Act and the European regulations
- Origin and scope of ISO 13485:2016
- Management responsibility
- Responsibility, authority, and communication
- Resource management, training
- Planning of product realization
- Development and design transfer
- Interfaces to risk management
- Procurement: Suppliers and Outsourced Processes
- Production and service provision
- Measurement, analysis, and improvement
Depending on whether you are interested in in-house training or the online seminar of the same name, the costs vary.
Learn more about quality testing and the management of quality. In your company – We look forward to seeing you!
Especially in the field of medical devices, internal audits are not only necessary for the maintenance and improvement of the quality management system, but are also intended to implement the technical and regulatory aspects of ISO 13485.. In this in-house training, which can also be held as an online seminar, you will learn more and deepen your professional knowledge on conducting an internal audit according to ISO 13485.
Our expert DI Martin Schmid explains to you in a practical way how you can conduct your internal audits competently and professionally using the right document templates and tools. In role plays, you will learn and practice the practical approach!
Participation in this seminar is only possible with prior knowledge of ISO 13485. As preparation and further training, we recommend our basic course on ISO 13485 at en.co.tec (see above).
The following areas are covered in the seminar on quality management audits:
Basics:
- Internal audit according to ISO 13485:2016
- Process management
The audit process:
- Audit program
- Audit preparation
- Audit execution
- Audit report
- Conclusion
Audit execution according to ISO 13485:2016:
- Reasons and objectives for audits:
- Definitions
- Audit methods
- Good audit practice
- Auditor qualification
Exercise example / role play:
- Audit program,
- Audit plan
- Audit execution
Best Practice: Training on typical strengths and weaknesses in certification and surveillance audits
In our event calendar, we not only offer basic courses and seminars on quality management—you will find a variety of different seminars for beginners and advanced participants in our event calendar.
Book online, contact us via seminare@encotec.at or by phone at +4318863491.
We build on our practical know-how and pass this on to you—both in training courses and in individual consulting. We build on our practical know-how and pass this on to you—both in training courses and in individual consulting.
The advantages of training or consulting for your optimized quality management are manifold:
Continuous consulting and monitoring
If you decide on consulting in quality management, we will support you in this process and review your previous processes with you.
High quality standard
Through our quality management courses, we optimize your knowledge of quality standards and keep you up to date on regulations and directives for medical devices.. Through consulting with our experts, you optimize your existing quality management, leading to fast and clear processes.
Relief of internal resources
The knowledge you acquire during a seminar relieves your internal resources in the long term. This gives you more time and energy for internal resources and provides extensive support for your quality management processes with the knowledge gained.
Practical know-how
Our consultants come from practical experience—so you can learn best for practical application. In our seminars, you gain insight into the broad expertise of our experts.
Our training courses & events
Are you interested in various areas related to quality management, regulatory approval, and standards of the medical device industry? and want to learn more about it as part of further training? In our trainings and events, you receive information and learn more about the requirements and how to skillfully implement them in your field.
Learn from the practical knowledge of our professionals in the course—trainings can also take place on-site at your company or online. Learn more and get in touch – we look forward to hearing from you!
