Medical Technology and Life Sciences Publications

Series: Ask an Expert, For Entrepreneurs

What are design controls and why are they important?

Question: What are design controls and why are they important? Answer: “Design controls” is a broad term that describes several procedures and processes used throughout the design and...

1 minute read

Risk Management, Emerging Growth, Global Solutions, Series: Risk Management 101, For Entrepreneurs

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...

2 minute read

Products Liability, Advertising and Promotion, Warnings and Labels, Series: Ask an Expert, Off Label Promotion, For Entrepreneurs

Products Liability Risks of Medtech Websites

Question: What are the regulatory and products liability risks associated with medtech companies' websites and online activities? Answer: To be a viable going concern today, it is...

5 minute read

Risk Management, Emerging Growth, Series: Ask an Expert, Claims and Litigation, For Entrepreneurs

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...

10 minute read

Clinical Trials, For Entrepreneurs

The Ethical Oversight of Clinical Trials: Institutional Review Boards

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...

8 minute read

FDA, Risk Management, Clinical Trials, Emerging Growth, Informed Consent, Series: Risk Management 101, For Entrepreneurs, Regulatory and Compliance

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...

2 minute read

Products Liability, Emerging Growth, For Entrepreneurs

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...

3 minute read

Risk Management, Clinical Trials, Emerging Growth, Informed Consent, Series: Risk Management 101, For Entrepreneurs

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...

2 minute read

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