QARA and clinical support for the medical device industry 

About QARA

QARA Consulting AB is a Swedish company based in Helsingborg and Stockholm. We are senior, expert consultants supporting clients in the medical device industry.

We offer a complete range of multidisciplinary quality and regulatory services from initial device classification, technical file writing and clinical evaluations, to post-market surveillance.

Over the years, our team has carried out various major assignments and established partnerships with clients, the industry and associations.


In order to broaden our services and increase our capacity, we use our network. All network partners are carefully selected and contracted to ensure that the work always live up to QARA quality.


Katarina Ortfelt

Katarina has worked in the international medical industry for over 20 years and has a thorough knowledge of quality assurance management and regulatory affairs. She has experience from building and setting up businesses in the medical device and life science sectors, IVDs, and GMPs. She has carried out numerous external and supplier audits and works regularly with the appropriate authorities worldwide. Likes to help in other´s success.

Maria Jansson

Maria has been with QARA since 2015. She has worked with finance in Sweden and abroad for over 20 years. She has experience as an accountant at small to mid-size companies, municipal operations and larger international organizations. She has run her own accounting firm since 2017.

QARA Consulting AB

Dalagatan 70 | SE-113 24 Stockholm | SWEDEN
Drottninggatan 27 | SE-252 21 Helsingborg  | SWEDEN

+46 (0)739 29 12 48

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