Publications
Emerging Growth
European Union “CE” Mark
Medical device manufacturers seeking to export products to European Union (EU) countries must consider whether they need to obtain the CE mark for their products. CE is an acronym for...
Patents: What New and Emerging Life Sciences Companies Should Know
Question:What Should New and Emerging Life Sciences Companies Know About Patents? Answer: Introduction to Intellectual Property Intellectual Property (IP) generally includes...
FDA Requirements for Informed Consent Forms
Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration...
The Future of Supply Chain Management
Question:What can the life sciences industry learn from the aerospace industry’s Nadcap program for supply chain management? Answer: Partly as a result of the growing complexity...
The Reimbursement Top Ten List | Medmarc
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...
MTLI: Education of the Industry, by the Industry and for the Industry
The Medical Technology Learning Institute (MTLI) is the education department of AdvaMed, an association whose member companies produce nearly 90 percent of the medical devices, diagnostic...
Drafting Informed Consent Forms | Medmarc
The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed...