The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks.
Medical device manufacturers seeking to export products to European countries must consider whether they need to obtain the CE mark for their products.
Food and Drug Administration (“FDA”) regulations establish the minimum requirements for all informed consent forms.
“Design controls” is a broad term that describes several procedures and processes used throughout the design and manufacture of a product.
What are the regulatory and products liability risks associated with medtech companies' websites and online activities?
What Should New and Emerging Life Sciences Companies Know About Patents?
Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers or...
Abstract: Clinical trials—medical research studies involving people—play an essential role in the advancement of medical science and technology. The information obtained from clinical trials is...
What Investors Will Ask and What Companies Should Know When Developing or Evaluating a New Medical Technology "Build it and they will come" is an anomaly in today's cost-conscious healthcare...
