At Innokas, we’re proud to have passionate experts like Sandra Hänninen on our team. As a Quality and Regulatory Affairs Specialist, Sandra plays a vital role in helping medical device developers navigate the complex path to market approval, whether in the EU or the US. “I help customers get their products through conformity assessment and achieve CE marking or FDA clearance,” Sandra explains. “It’s a big process, and I’m involved at different stages depending on the project.”

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From building regulatory roadmaps to establishing quality management systems and compiling technical documentation, Sandra’s work ensures that innovative medical devices meet the highest standards. But for her, it’s more than just compliance, it’s about impact.

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From compliance to impact

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“One day, my son asked me what I like best about my job,” she recalls with a smile. “I showed him a customer’s product and said, ‘We helped bring this to market. This device can save lives.’ That’s when it really hit me; what we do matters.”

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Sandra’s enthusiasm is contagious. She lights up when talking about the diversity of devices she supports, and the inspiring innovations Innokas’ customers bring to the table. “Each device is unique and helps different patient populations. It’s amazing to be part of that journey.”

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Her passion extends beyond project work. Sandra has recently shared her expertise in industry events, something she finds both rewarding and enriching. “When I prepare for a talk, I take a deep dive into the topic. I always learn something new, and I love making complex topics understandable for everyone listening in.”

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Collaboration, values, and sharing expertise

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Sandra values the collaborative spirit at Innokas. “My team is lovely,” she says warmly. “We work remotely, but when we met in person in Helsinki, it was wonderful. Our work is demanding, and we really support each other through it all.”

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When asked about the values she shares with Innokas, Sandra doesn’t hesitate. “Quality, responsibility, expertise, and meaningfulness, all of them are part of my daily work. We’re accountable to regulatory bodies, so we can’t cut corners. And the meaningfulness? That’s what keeps me going.”

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She was asked to share some advice with medical device developers: “Get regulatory input as early as possible. It really helps avoid complications down the line. We’re here to help, and we love doing this.”

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Sandra’s story is a reminder of the people behind the scenes who make medical innovations possible. With her dedication and knowledge, she’s helping life-saving devices reach the markets and ultimately helping to improve lives.

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