The European business environment for medical device companies is changing fast. New laws, regulations and guidance thereof impose new requirements for new but also already marketed products. An increasing demand for clinical data before and during registration processes will result in more activities in that field. And although this renewed environment looks more and more like a pharma environment, substantial differences remain present: medical devices are no pharmaceuticals and vice versa.
At Lacidem we have the unique knowledge and experience of both worlds. We understand the differences and, more important, know what works and what does not work for medical devices. We partner with our customers and support them, especially also in the transition process from MDD/ AIMD to MDR. Our customers range from new, start-ups to established companies. New companies lacking medical or clinical capacity but that need the expertise bringing new products to the market. Or established companies with new or already CE marked products requiring clinical or medical "maintenance" activities.