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Mediteq

Er regulatoriska kompetens, från idé till färdig produkt!

  • Consulting services
        • Consulting
        • Operational management
        • PRRC

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          • Audit
          • Biological evaluation
          • CE-marking
          • Clinical evaluation
          • GAP analysis
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          • Regulatory strategy
          • Risk management
          • Safety Monitoring
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Mediteq Svenkebo AB

Kanalstråket 1

433 76 Jonsered

LinkedIn

031 774 25 001

contact@mediteq.se

Our consultants
About Mediteq
Consultant at Mediteq
Our new colleague?

Our consultants

Petra Rosén

Consultant

Jennie Bengtsson

Consultant

Matilda Eriksson

Consultant

Emilie Andersson

Consultant

Lina Siverholm

Office Manager

Sofia Blad

Consultant Manager and Senior Consultant

Herman Fahlström

Education Manager and Senior Consultant

Helen Sandelin

CEO and Senior Consultant

About Mediteq

Mediteq was started in 2007 by Helen Sandelin and has developed into a small consulting company with big ambitions. Helen Sandelin’s work with medical technology and IT systems began back in 1995, creating a solid foundation for Mediteq and our future development.

Mediteq also operates the competency network Mediteq Forum.

All businesses have different needs in a management system, depending on the organization and the products that the business develops and offers. The path to an effective and representative management system is often lined with tricky questions and you can get lost between various standards and regulations. By hiring Mediteq, you get access to solid experience in implementing and customizing management systems, a perfect companion on the way to your optimal management system.

Mediteq is represented in two of Sweden’s committees for the development of international standards:
IEC Technical Committee 62 – develops standards around electrical medical technology products
ISO Technical Committee 355 – develops standards around quality management systems for medical devices
ISO Technical Committee 334 – develops standards around Healthcare informatics for medical devices.

Representation in these technical committees gives Mediteq an opportunity to be the first to know about updates, additions and changes to current standards, as well as information about upcoming standards and how they could affect medtech companies. Mediteq are members of MEDEA, a trade association for medical technology consultants. MEDEA was started on the initiative of the Medical Products Agency (LV), and aims to increase transparency and exchange of information between LV and consulting companies in medical technology. We are members of Regulatory Affairs Professional Society (RAPS), which is an international organization for regulatory experts in medical technology. Our customers are large international companies, small and medium-sized companies, companies undergoing reorganization, innovative start-ups and organizations in healthcare.

Among other things, Mediteq has worked with the following products:

  • ECG and patient monitoring
  • Electronic record systems
  • Ventilators
  • Sterile products, i.e. wound care
  • Hospital beds
  • Communication and alarm systems
  • Products for IVF
  • Implants
  • Multiple types of analytical software
  • IVD and related software
Contact Mediteq!

Being a consultant at Mediteq

Working as a consultant at Mediteq is exciting, challenging and varied. Our consultants work closely with our customers and assists in, among other things, advice, operational management, development, analysis and follow-up of technical documentation, management systems, product registrations, reviews, evaluations, audits, authority reporting and follow-up on the market.

We want our employees to feel good, develop and have fun at work!

At Mediteq, it is of utmost importance that you thrive and evolve with us and with our customers. We want our consultants to feel like part of Mediteq and that together we develop Mediteq as a consulting company, knowledge broker and training company.

Our competence network Mediteq Forum gives both consultants and members the opportunity to strengthen their competence and exchange experiences with colleagues, companies and organizations within the industry. At our meetings and activities, you as a consultant have the opportunity to participate in training courses held by colleagues, get involved in industry organizations or standardization work. Perhaps you are our next training leader in your area of ​​expertise?

During the week, we mainly work with our customers and at Friday’s breakfast meeting we summarize the current situation and plan ahead. It is also here that we give time to focus on the development of Mediteq, Mediteq Forum and ourselves.

Apply with your CV now!

Are you our new colleague?

We are looking for those who are committed, responsible and positive! In the role as a consultant, it is important that you are able to communicate, collaborate and take initiatives. You’re very good at planning, coordinate, complete tasks and follow up results, while making sure to have a continuous dialogue and collaboration with customers and others involved in your project. To thrive as a consultant at Mediteq, you should enjoy varied tasks and you’re good at gathering and analyzing data and information, as well as presenting the results of your analysis. It is also important that you are a skilled educator.

Qualifications

  • Relevant academic degree in medical technology, IT, biomedicine, technology or similar.
  • Minst två års erfarenhet av forskning, kvalitetsarbete eller regulatoriskt arbete. Detta kan blanda annat innebära att du har erfarenhet av avvikelsehantering, kliniska studier, internrevision, produktregistrering, kvalitetssäkring av produkt, projekt eller process. Att skriva, granska eller sammanställa teknisk dokumentation samt stöd under produktutveckling och produktutvärdering.

Meritorious

  • Educator
  • Medical technology software and IT systems
  • Clinical data and studies
  • In-vitro diagnostic products

Mediteq strives to be a personal, professional and customer-oriented consulting company. Meeting our customers with clarity and respect is central to us.

Our office is located in Jonsered.

If you have questions or want to know more about what it is like to work with us, you are welcome to

contact our consultant manager Sofia Blad at 0733-72 60 23.

E-mail us your resume!

Prenumerera på vårt nyhetsbrev







LinkedIn

031 774 25 00

contact@mediteq.se

Mediteq Svenkebo AB

Kanalstråket 1

433 76 Jonsered