NanoEcho Strengthens its Regulatory Competence

As part of the company’s development, NanoEcho is strengthening the organisation by adding regulatory expertise to the management team. Kristina Hallström will bear responsibility for Quality Assurance and Regulatory Affairs, with a particular focus on market approval for NanoEcho’s system.

Kristina Hallström, Head of Marketing and Communication at NanoEcho, now has an expanded remit. She boasts extensive experience in working strategically with clinical issues and regulatory matters. In recent years, she has been active as a medical technology consultant with a clinical and regulatory focus. At NanoEcho, Kristina will work actively together with clinics, product developers and authorities, all with a view to securing market approval for NanoEcho’s system.

Kristina has taken on this assignment gradually. During the autumn, the company worked on developing a regulatory strategy, selected a Notified Body to certify the quality management system, and applied for – and was granted – a Vinnova grant for regulatory work.

‘I am very happy that Kristina has chosen to expand her corporate responsibility and also taken on this key regulatory work. I feel we are in safe hands with Kristina in the management team, where she is a great asset and contributes on many fronts with the breadth and depth of her experience,’ says Linda Persson, CEO at NanoEcho.

‘It will be exciting to drive the process of getting market approval for our system – something we do by showing, step by step, that our system is both clinically useful and meets all the authorities’ requirements,’ says Kristina Hallström.

Since October 17, Kristina has been working full-time at the company with responsibility for Marketing, Communications, Regulatory Affairs and Quality Assurance.

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