Medical Technology and Life Sciences Publications

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, 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

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

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, 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

Publications

Risk Management (2)

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Quality System

European Union “CE” Mark

Managing Foreign Supply Chains to Avoid Importing Risk

Risk Management 360: Managing Risk Through Product Recall Preparation

Contracts

Patents: What New and Emerging Life Sciences Companies Should Know

Complaint Handling for Medical Device Manufacturers

The Credentialing Morass

Defending a Products Liability Lawsuit

Developing a Medical Device Recall Action Plan