Andreea Matei
System Engineering in Healthcare Technology
"Live documentation is critical for meeting regulatory demands without delays."
Andreea Matei is a Project Manager at Cicor MedTec Bucharest, Romania. We spoke with her about why structured documentation is a game-changer in MedTech and how Cicor helps customers turn this into a competitive advantage.
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System Engineering in MedTech – Andreea Matei’s Full Interview
Andreea, why is documentation such a critical factor in healthcare technology today?
With regulations like MDR and IVDR in force, documentation, traceability, and risk analysis are no longer optional, but essential for market access. The industry is moving toward documentation-driven development, meaning every stage of design, verification, and manufacturing needs to be linked and auditable. Without this, even great innovations can face delays or fail to reach the market.
What are the biggest challenges that MedTech companies face in this area?
One of the biggest gaps is between engineering innovation and regulatory documentation. Many companies still see them as separate, which leads to inconsistent or incomplete records. This can make certification slow and costly. There’s also a lack of integrated tools to align requirements, risks, and verification from the start.
“With MDR and IVDR, compliance must be built in from the very first design step.”
How can this gap be tackled?
We integrate documentation directly into the system engineering workflow. Using ALM platforms such as Helix ALM and Polarion ALM, we connect requirements, risks, test cases, and verification results into a live, traceable Design History File. This approach ensures that compliance is built into the product from the very first concept, not treated as an afterthought.
At Cicor, I’ve seen how having hardware, software, mechanical, and quality teams working closely together keeps everything aligned. Documentation evolves naturally with the product, so when the time comes for manufacturing or regulatory submission, there are no last-minute surprises.
What makes Cicor’s approach unique compared to other providers?
We combine strong engineering capability with manufacturing expertise, all under one roof, in locations across Europe, Asia, and Africa. This global footprint means we can develop and produce medical devices close to our customers, scaling from prototype to volume manufacturing without disruptive handovers. We integrate design for manufacturing right from the start, supported by tools like Helix ALM and Polarion ALM to maintain full traceability and up-to-date documentation throughout the process. This reduces risk, accelerates time-to-market, and ensures regulatory readiness at every stage.
"Rapid prototyping and early DFM input give our customers a smoother path to production."
Where do you see MedTech product development heading in the next few years?
The demand for portable, connected, and miniaturised devices will keep growing, especially in wearables, smart diagnostics, and home-based healthcare. At the same time, documentation and traceability requirements will become more stringent under MDR, IVDR, and FDA regulations. Companies that integrate compliance into their engineering processes from the start, using structured, tool-based workflows, will have a clear advantage. This is where Cicor’s combination of multidisciplinary engineering, rapid prototyping, and manufacturing capability can help customers get to market faster and with fewer risks.
What excites you most about your work in this area?
I enjoy linking technical work with clear processes and working with highly qualified, multidisciplinary teams. It is satisfying to see how structured system engineering can bring together all the elements – mechanical, hardware, software, and documentation – into a reliable, market-ready medical device.
Final question – what’s something you can’t do your job without?
Good planning tools and open communication are essential. And, of course… a good cup of coffee always helps!
About Andreea
Andreea Matei is a Project Manager at Cicor MedTec Bucharest, Romania. With a PhD in Physics and more than 18 years of experience in laser processing, advanced materials, and microelectronics, she now focuses on bridging engineering innovation with regulatory compliance in the medical sector.
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