Medical Technology and Life Sciences Publications

Risk Management, Supply Chains, Outsourcing, Series: Risk Management 101

Supplier Controls

Medical device manufactures often use component parts provided by a supplier to complete a finished medical device. Manufacturers should be concerned with the reliability of supplier...

2 minute read

FDA, Risk Management, Series: Risk Management 101, Regulatory and Compliance

Quality System

The term "quality" refers to a medical device's fitness for its intended use. To ensure quality, the Food and Drug Administration (FDA) requires the manufacturers of medical devices to...

2 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

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

Risk Management, Products Liability, Series: Risk Management 101, Claims and Litigation

Defending a Products Liability Lawsuit

Medical device and drug manufacturers have no intent or desire to introduce harmful devices or drugs into the marketplace. In addition, FDA’s strict regulation of these companies is...

2 minute read

Risk Management, Series: Risk Management 101, Recalls

Developing a Medical Device Recall Action Plan

Medical device recalls are initiated when a medical device is defective, poses a risk to health, or both. The medical device manufacturer is generally charged with voluntarily initiating...

2 minute read

Risk Management, Global Solutions, Series: Risk Management 101, Claims and Litigation

The Foreign Corrupt Practices Act

What is the Foreign Corrupt Practices Act? The Foreign Corrupt Practices Act (FCPA) is a federal law that makes it illegal for companies to make payments to foreign government officials...

2 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, Products Liability, Series: Risk Management 101, Claims and Litigation

Spoliation of Evidence

Upon becoming aware of a potential or actual lawsuit, the relevant parties have a responsibility to preserve any evidence potentially related to it. A party who purposely or negligently...

2 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

Series: Risk Management 101

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