In today’s rapidly evolving healthcare landscape, ensuring the safety and effectiveness of medical devices is of paramount importance. To address this, the European Union (EU)

Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between

Commercialising your medical device or IVD first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell

Here we will try and explain the processes involved from a Regulatory and Quality Assurance perspective of what is involved in the design and development