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

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

Risk Management, Products Liability, Adverse Event Reporting, Sales Reps, Warnings and Labels, Series: Risk Management 101, Claims and Litigation

The Learned Intermediary Doctrine

The Doctrine The Learned Intermediary Doctrine provides that a drug or medical device manufacturer has no legal duty to warn consumers of a drug or medical device’s harmful side effects...

1 minute read

Risk Management, Sales Reps, Warnings and Labels, Series: Ask an Expert, Off Label Promotion

Off-Label Promotion

Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...

4 minute read

Distributors, Sales Reps, Series: Ask an Expert, Off Label Promotion

Manufacturer Contact with Patients

Question:What should life sciences manufacturers do if contacted by patients? How much information can the manufacturer pass along, if any? Answer: When responding to a patient...

4 minute read

Distributors, Sales Reps, Series: Ask an Expert, Claims and Litigation

Sales Reps and the Practice of Medicine

Question:When is a medical-device sales representative who is present in a clinical setting engaging in the practice of medicine? Answer: With today’s high-tech surgical...

3 minute read

Sales Reps

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

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

The Credentialing Morass

The Learned Intermediary Doctrine

Off-Label Promotion

Manufacturer Contact with Patients

Sales Reps and the Practice of Medicine