Medical Technology and Life Sciences Publications (4)

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, Products Liability, Supply Chains

Managing Foreign Supply Chains to Avoid Importing Risk

Having more partnerships with foreign manufacturers means that U.S. companies must be aware of liability concerns and the safety of imported products. The global economy has caused...

11 minute read

Series: Ask an Expert, Off Label Promotion, Claims and Litigation

FDA Prosecution under the Park Doctrine

Question:What is the Park Doctrine and how is the FDA using it to criminally prosecute corporate officers of life sciences companies? Answer: Following heavy-handed rhetoric by...

2 minute read

Risk Management, Series: Risk Management 360, Recalls

Risk Management 360: Managing Risk Through Product Recall Preparation

In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and...

11 minute read

Risk Management, Products Liability, Series: Products Liability 360, Contracting

Contracts

Introduction The supply chain for medical devices and diagnostic equipment can be fairly complex.Raw material suppliers sell to component part manufacturers who sell to final...

7 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

Risk Management, Medical Device Manufacturers, Series: Risk Management 101

Complaint Handling for Medical Device Manufacturers

Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include:...

2 minute read

Animal Health, Case Study, Claims and Litigation

Case Study: Animal Dewormer

ANIMAL HEALTH PRODUCTS EXECUTIVE SUMMARY: This case involves an equine dewormer used by a horse breeding operation. Fifty-four horses deceased shortly after use of the product, and their owner...

3 minute read

Risk Management, Products Liability, Sales Reps

The Credentialing Morass

Imagine, for a moment, that there are no uniform traffic regulations in the United States and the design of signs, lights, lane markings and all other infrastructure is left to the whim...

4 minute read

Products Liability, Pharmaceuticals, Preemption, Series: Ask an Expert, Claims and Litigation

Mensing and Its Impact

Question:What is Mensing and what is its impact for generic-drug manufacturers? Answer: In Pliva, Inc. v. Mensing1, the U.S. Supreme Court provided its latest pronouncement on...

3 minute read

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