What is a technical file for a medical device? A medical device technical file is a concise report created by a manufacturer to explain the
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
Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital
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
Medical devices must be of high quality to be considered safe on the market. Strict safety and quality regulations must be met to achieve this.
Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at
Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must be followed based on the
This blog will explain the Person Responsible for Regulatory Compliance (PRRC) MDR service and the necessary steps to ensure that your medical device is compliant
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