At GBA Key2Compliance, the Clinical Research Organization (CRO) team is not only responsible for navigating regulatory requirements but also for ensuring that medical devices make their way into the hands of patients safely and effectively. In a field where innovation is critical but patient safety is non-negotiable, clinical evaluations play a vital role.
At the forefront of this work are our clinical evaluation experts whose dedication to quality, safety, and long-term client success is key to driving progress in MedTech. One of these experts is Sandra Sernbo, who combines deep scientific expertise with a passion for helping clients navigate complex regulatory landscapes.
From Idea to Real-World Impact – Sandra’s Work in Clinical Evaluations
Sandra Sernbo works at the point where a medical technology idea must be demonstrated, refined, and made safe enough to be used in healthcare. Her mission is to ensure that a device truly does what it is intended to do and provides real benefit for users and patients.
Scientific expertise with practical relevance
Sandra holds a PhD in Immunotechnology and has years of experience in cancer research. During her time in academia, she sometimes missed the direct connection between scientific discovery and tangible benefit for patients. In clinical evaluations, that connection became clear.
“I realized how my research background could contribute to ensuring that medical devices are not only effective but truly safe,” she says.
Her analytical mindset combined with a practical approach, helps her translate complex data into evidence that reflects how a product performs in real clinical use.
Building trust through clinical evidence
Trust from healthcare professionals and users is what matters most. Sandra views clinical evaluations primarily as a way to create that trust, rather than just as a mandatory compliance exercise.
“The important part is showing that what is promised actually holds up in real use,” she explains.
Regulations such as MDR and IVDR help structure this proof. They act as a quality filter that ensures innovations can be used safely once they reach patients.
Finding the way forward when challenges arise
In many cases, Sandra’s work involves guiding companies to understand the evidence required to demonstrate safety and performance. This applies especially to companies that do not always have the resources or the competence in the clinical development process from a regulatory perspective.
“When the intended purpose and claims are not clearly defined, uncertainty spreads throughout the entire process,” she says.
She recalls a project where the reviewer raised extensive concerns. By identifying the critical gaps, Sandra and the team turned the situation into a successful approval.
“What matters is understanding the clinical context and making sure the evidence answers the right questions,” she emphasizes.
Her role is to reconnect everything to the clinical benefit and define a clear path forward, especially when a company feels stuck.
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People at the center of the process
Trust is central to how Sandra works. She collaborates closely with her clients, ensuring open communication and a shared focus on both the immediate challenge and the long-term clinical strategy behind their products. The aim is not only to achieve a successful review, but to strengthen the company’s ability to generate and communicate clinical evidence throughout the product’s lifecycle.
This trust also needs to extend into interactions with regulatory bodies. Clear expectations, transparent documentation, and constructive dialogue help reviewers understand the product and the science behind it. By fostering confidence on both sides, Sandra supports a smoother and more predictable path from innovation to real clinical use.
The Role of Technology and Continuous Learning
Digital tools, medical device software, and AI are reshaping the MedTech landscape. Increased efficiency is welcome, although Sandra notes that no system replaces human understanding of clinical context.
“No algorithm can replace the personal connection and insight needed in this field,” she says.
“Every product and every company has nuances that matter.”
At GBA Key2Compliance, Sandra collaborates with colleagues in clinical development and regulatory affairs. Each contribution helps ensure that a product reaching healthcare is not only innovative, but reliable and safe for those who depend on it.
Let us guide you through your next challenges
At GBA Key2Compliance, we offer more than just regulatory guidance. We are partners in innovation, helping you bring your medical device to market safely and effectively.
Our team has the knowledge, experience, and dedication to ensure that your device meets all regulatory requirements while remaining focused on patient safety and clinical success.
Need expert guidance in clinical evaluations? Find out how we can help.
Contact us today to learn how our personalized approach can assist you.