Mediteq offers training
in the medical device and in-vitro diagnostic area.
We provide training with enthusiasm and energy, always with your needs in mind!
Interested in our next training? Check out our calendar in Swedish!
Customized training
Mediteq offers training on several topics related to regulatory requirements and quality for medical devices. We deliver both basic and in-depth training as well as workshops. Our training is customized to various types of actors in the industry such as manufacturers, healthcare providers, subcontractors, suppliers, consultants, distributors, and others.
Mediteq offers training in the following areas for medical device companies:
- CE marking
- Regulations – MDR and IVDR
- Management systems
- Internal auditing
- Risk management
- Product development
- Software development
- Clinical evaluation and follow-up
The scope and length of our training vary from a half-day introduction to several days of in-depth training customized to the participants’ prerequisites and needs. The training is tailored to your organization and product type, e.g various requirements for implants, electrical products, or software products.
Mediteq can conduct the training on-site at your facility or from our webstudio.
Our trainers have many years of practical experience in the medical device industry and keep up-to-date in the regulatory area with engagement in standardization and industry organizations.
We look forward to teaching you and your colleagues more about our favorite subjects – regulations, legal requirements, and standards for medical devices.
If you want to discuss your training needs with us, please contact us for customized training.
Lead Auditor training
Mediteq is proud to host an extensive and highly interactive Lead Auditor Training course for ISO 13485:2016 in Gothenburg area.
You are welcome to participate if you have knowledge in ISO 13485:2016 and have multiple experience of ISO Medical Device audits as either an auditor or auditee. The more experience you have from working with QMS and auditing, the better skills you will gain from the course.
Target audience, Auditors and internal auditors at manufacturers, contract manufacturers, suppliers, Notified Bodies and Competent Authorities as well as quality managers, regulatory managers, QMS managers and quality personnel in the medical device industry.
The course is IRCA certified.
Lead Auditor training organized by Mediteq received 5 out of 5 stars from all participants, both regarding the training as a whole, our training leaders, and the usefulness of the knowledge in the participants’ daily work – simply a success!
5 steps to CE marking!
Workshop series for Start-ups
- Workshop 1 – Strategy
- Workshop 2 – Mapping: define and limit
- Workshop 3 – Plan for the product
- Workshop 4 – Plan for the organization; Pre- and post-launch
- Workshop 5 – Market access: resources and time
Are you working on a fantastic idea or have developed medical device but are not familiar with what is required to CE mark and gain market access?
Mediteq has a training for those who want to get clarity and practical help with what is required for your product, product idea or concept to be approved for use in the EU or perhaps the US.
The training is divided into five workshops, where we alternate theory and practice with discussions and home assignments.
All adapted to your idea, product and organization!
E-learning
Mediteq offers a digital training course in Swedish for requirements and regulations of medical devices. In 29 web-based lessons we present the basics of MDR 2017/745 and provide an overview of the requirements for CE marking a medical device and to be sold in EU. Our e-learning provides you as a participant with the opportunity for flexible and time-efficient competence development. For organizations and companies, our e-learning is a cost-effective way to offer competence development to all employees, either at individual occasions or long-term.
The e-learning includes:
- 29 web-based lessons in Swedish
- Knowledge questions after each lesson
- Digital material to download
- Certificate of completion
Open training
Mediteq has been a training leaders for SIS, Svenska Institutet för Standarder since 2015. Here you can learn the basics of MDR or IVDR regulations, management systems, internal auditing, risk management and medical software.
