In the pharmaceutical industry, mobile devices are increasingly being used in corporate processes to exchange data with scientists, doctors, patients and participants in clinical tests. The latest technologies enable the pharmaceutical and medical world to exchange data, collect and process data faster, diagnose patients outside traditional health care settings, get closer to patients and help them manage their own health and wellness.
However, mobile devices and applications present a significant challenge to control. To guarantee the safety and reliability of these technologies, they must meet specific regulations and guidelines – for example the recent ISO 13485 legislation. This especially applies when those applications could present a risk to users if they do not operate as intended. This compliancy of mobile devices and mobile applications is a relative new part of the validation process of organisations.
QbD is happy to take care of the validation of your mobile devices and applications. With clients in the pharmaceutical, biotechnological, cosmetics and healthcare sectors, we are always up to date on the latest guidelines and legislation. We know the mobile application process from A to Z and offer extensive services – from a risk analysis to the creation of a Design History File. Supported by our validation experts, you are able to bring new products onto the market care-free, showing auditors that your applications and devices are compliant and safe.
Contact us to discuss your project