Medical Technology and Life Sciences Publications

Distributors, Sales Reps, Series: Ask an Expert

What should a medical device sales representative do if she observes a surgeon using a medical device incorrectly during a procedure?

Question: What should a medical device sales representative do if she observes a surgeon using a medical device incorrectly during a procedure? Answer: While in the operating...

1 minute read

Adverse Event Reporting, Distributors, Sales Reps, Series: Ask an Expert

What should a medical device sales representative do if an adverse event occurs during a procedure?

Question: What should a medical device sales representative do if an adverse event occurs during a procedure? Answer: Medical device sales representatives must report adverse...

1 minute read

Series: Ask an Expert, Recalls

Product Traceability and Recall Procedures

Question: Product recall can be a serious challenge for manufacturers. What should a manufacturer do to ensure product traceability and what procedures should a manufacturer follow to...

3 minute read

Series: Ask an Expert, Claims and Litigation

Electronically Stored Information (ESI)

Question: What is electronically stored information and what should my life sciences company do to preserve it? Answer: Electronically stored information (“ESI”) and its...

3 minute read

Warnings and Labels, Series: Ask an Expert

Unique Device Identifier (UDI) Fundamentals

Question: What can life sciences companies expect from the UDI program? Answer: Although many in industry may be quick to view the UDI as only a “labeling rule,” the impact of...

4 minute read

FDA, Products Liability, Series: Ask an Expert, Regulatory and Compliance

Warning Letters & Products Liability

Question: If my company gets a Warning Letter from the FDA, how will it affect our products liability litigation? Answer: A company’s first priority is to deal with the FDA’s...

1 minute read

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

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

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, 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

Series: Ask an Expert

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