Medical Technology and Life Sciences Publications

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

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

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

Supply Chains, Outsourcing, Series: Ask an Expert, Claims and Litigation

Claims Burgeoning in California Courts

Question:Why are we seeing more life sciences cases in California? Answer: One of the biggest obstacles facing defendants in medical device litigation is jurisdiction and forum...

3 minute read

Risk Management, Supply Chains, Global Solutions, Outsourcing, Series: Ask an Expert

Mitigating the Risks of Foreign Suppliers

Question:How can life sciences companies mitigate the products liability risks associated with using foreign suppliers? Answer:As pricing pressures weigh on medical device and...

2 minute read

FDA, Risk Management, Products Liability, Supply Chains, Regulatory and Compliance

Effective Supply Chain Management for Medical Device Shipments

Medical device manufacturers face a daunting challenge in today's market. In addition to understanding stringent government regulatory requirements and FDA-mandated current Good...

4 minute read

Products Liability, Supply Chains, Distributors, Series: Ask an Expert, Insurance and Policy Issues

Do distributors require professional liability insurance coverage in addition to products liability insurance coverage?

Question:Do distributors require professional liability insurance coverage in addition to products liability insurance coverage? Answer: No, at least not “professional...

1 minute read

Supply Chains, Emerging Growth, Outsourcing, Series: Ask an Expert

The Future of Supply Chain Management

Question:What can the life sciences industry learn from the aerospace industry’s Nadcap program for supply chain management? Answer: Partly as a result of the growing complexity...

3 minute read

Products Liability, Supply Chains, Contract Manufacturing, Distributors, Outsourcing, Series: Products Liability 360

Component Parts and Raw Materials, Successors, and Distributor Liability

Introduction Now that we have discussed the four main theories of liability that can arise when selling a product – manufacturing, design, warnings and instructions, and marketing...

13 minute read

Supply Chains

Filtered on