Medical Technology and Life Sciences Publications (2)

FDA, Risk Management, Products Liability, Supply Chains, Clinical Trials, Regulatory and Compliance, Article

IMDA: Together We're Better

Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers...

2 minute read

FDA, Risk Management, Products Liability, Supply Chains, Clinical Trials, Regulatory and Compliance, Article

Employee Participants In Clinical Trials

Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...

6 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

Contract Manufacturing, Series: Contract Manufacturing, Article

The CMO Landscape: Diversifying to Meet an Evolving Industry

The CMO Landscape: Diversifying to Meet an Evolving Industry Part one of a three-part series on the Contract Development and Manufacturing industry and potential products liability and...

2 minute read

Contract Manufacturing, Series: Contract Manufacturing, Article

CMO FDA Regulation: Are CMOs Regulated by the FDA?

Are CMOs Regulated by the FDA? Part two of a three-part series on the Contract Development and Manufacturing industry and potential products liability and manufacturers E&O risks. Medical...

2 minute read

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