Biomedical engineering is a rapidly growing field that combines the principles of engineering and biology to develop innovative solutions for healthcare challenges. From designing artificial organs to creating new medical imaging technologies, biomedical engineers are at the forefront of advancing medical research and improving patient outcomes. In this blog post, we will delve into the […]
Working with notified bodies during the development process of medical devices can be a complex and challenging task. Notified bodies are third-party organizations that are designated by a country’s regulatory body to conduct audits and certify that medical devices comply with the relevant regulations and standards. In order to successfully navigate the process of working […]
Audits are a staple part of life sciences companies such as pharmaceutical companies, medical or biologic device manufacturers, and many more in the industry, and are key to success. While an audit gives a company valuable feedback on the quality of their processes and products, failing an audit can have a range of consequences from […]
Life sciences is a vast and interdisciplinary field that encompasses a range of scientific disciplines that focus on the study of living organisms and their interactions with each other and their environment. Some of the key areas of study within life sciences include biology, biochemistry, genetics, and molecular biology. One of the main goals of […]
An FDA audit is inevitable for any organization that manufactures or processes medical equipment, devices or drugs. Once the inspector enters the building, it might leave your leadership and team members feeling one of two ways: A calm excitement for the prepared organizations that are prepared and ready to successfully go through the audit, or […]
The medical device industry landscape of regulations is constantly changing. The European Union’s Medical Device Regulations (EU MDR) came into effect on 26 May 2021 after a three-year transition period, is no exception. The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices […]
GMP audit
5 benefits to implementing a GxP quality management system (QSM) software:
Success or Death by CAPA
Life Sciences Cyber resilience
