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)
A vital starting point and manual for the clinical evaluation of your medical device is the Clinical Evaluation Plan, or CEP. Find out more about
Medical Device Startups – is not applying a regulatory strategy early on costing them more in the long run?
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
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
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
The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation. It is known as the