Medmarc News and Resources

Medmarc Business Network Launched

Wed, 20 Oct 2010 04:00:00 GMT

AdvaMed 2011 - The MedTech Conference

Fri, 05 Aug 2011 04:00:00 GMT

Sara Dyson to Present at Advamed MTLI Workshop

Mon, 08 Aug 2011 04:00:00 GMT

AdvaMed MTLI Implementing Risk Management Workshop

Thu, 04 Aug 2011 04:00:00 GMT

Sara Dyson to Present at Supplier Quality Management Congress

Fri, 01 Jul 2011 04:00:00 GMT

In3 Summit 2011

Sat, 06 Aug 2011 04:00:00 GMT

Animal Healthcare Technology Insurance

Sat, 02 Jul 2011 04:00:00 GMT

Leaders in Clinical Trials Insurance

Fri, 05 Aug 2011 04:00:00 GMT

Medmarc Joins Florida Medical Manufacturers' Consortium

Wed, 10 Aug 2011 04:00:00 GMT

A 30-year Success Story: The Origins of Medmarc Insurance Group

Fri, 06 Mar 2009 05:00:00 GMT

Council on Litigation Management announces its 2011-2012 State Chairs

Mon, 03 Oct 2011 04:00:00 GMT

Chief Underwriting Officer Fran Stockwell Celebrates 25 Years of Service to Medmarc

Mon, 07 Nov 2011 05:00:00 GMT

Medmarc Sponsors the 5th Annual OneMedForum San Francisco 2012

Tue, 06 Dec 2011 05:00:00 GMT

Sara Dyson to Present at Supplier Controls and Quality Management Conference 2012

Mon, 09 Jan 2012 05:00:00 GMT

Sara Dyson to Present at MD&M West Conference

Tue, 10 Jan 2012 05:00:00 GMT

In3 Medical Device 360

Mon, 16 Jan 2012 05:00:00 GMT

Sara Dyson to Present at Ninth Annual Medical Device Quality Congress

Mon, 27 Feb 2012 05:00:00 GMT

Sara Dyson to Present at AdvaMed MTLI - Recalls from A to Z

Fri, 24 Feb 2012 05:00:00 GMT

Sara Dyson to Present at Medical Device Workshop on FDA Inspections, Warning Letters, & CAPA

Tue, 15 May 2012 04:00:00 GMT

IN3 Medical Device 360 - Boston

Wed, 16 May 2012 04:00:00 GMT

The Biomaterials Access Assurance Act

Wed, 13 Apr 2011 04:00:00 GMT

Do I need a BOP? How to insure my emerging growth life science company

Thu, 14 Apr 2011 04:00:00 GMT

How to Avoid Off-Label Device Promotion

Mon, 22 Feb 2010 05:00:00 GMT

Case Study: Which Way Do I Turn? Understanding the difference between professional liability and products-completed operations

Wed, 11 May 2011 04:00:00 GMT

Employee-Participants In Clinical Trials

Mon, 31 Jan 2011 05:00:00 GMT

Insurance Considerations for Global Clinical Trials

Thu, 06 May 2010 04:00:00 GMT

Minimizing Risk When Obtaining Informed Consent

Wed, 18 Aug 2010 04:00:00 GMT

The Ethical Oversight of Clinical Trials: Institutional Review Boards

Mon, 22 Feb 2010 05:00:00 GMT

Protecting PMA Devices and Their Makers

Sun, 01 Feb 2009 05:00:00 GMT

Federal Preemption Survives Attack

Tue, 28 Apr 2009 04:00:00 GMT

Risk Shifting Through Contracts

Mon, 19 Jul 2010 04:00:00 GMT

Managing Global Supply Chains to Avoid Importing Risk

Tue, 17 Feb 2009 05:00:00 GMT

Document Management: How Life Sciences Technology Companies Can Protect Themselves

Tue, 28 Apr 2009 04:00:00 GMT

White Paper: A Prescription for Managing the Risks of Off-Label Promotion

Wed, 06 Jan 2010 05:00:00 GMT

Another Step to Claim Resolution With a Medicare Claimant

Thu, 03 Sep 2009 04:00:00 GMT

Case Study: Risk-Shifting Through Contract

Wed, 27 Aug 2008 04:00:00 GMT

What Lies Ahead for the MedTech Industry

Fri, 06 Mar 2009 05:00:00 GMT

The Reimbursement Top Ten List

Tue, 26 Oct 2010 04:00:00 GMT

Medical Device Innovation: Avoiding Failure by Managing Risk

Tue, 26 Oct 2010 04:00:00 GMT

Ouch!: Managing Risk from Needlestick Injuries

Fri, 23 Jul 2010 04:00:00 GMT

Q&A: International Clinical Trials - Why Specialized Expertise Matters

Fri, 23 Jul 2010 04:00:00 GMT

Changing Times: What Buyers of Legal Services Need to Know Now

Fri, 23 Apr 2010 04:00:00 GMT

Do Your Products Only Expose Your Firm to Bodily Injury and Property Damage?

Fri, 23 Apr 2010 04:00:00 GMT

AdvaMed: Ensuring Medical Innovation for All

Wed, 16 Dec 2009 05:00:00 GMT

IMDA: Togther We're Better

Wed, 16 Dec 2009 05:00:00 GMT

MTLI: Education of the Industry, by the Industry and for the Industry

Wed, 16 Dec 2009 05:00:00 GMT

The Courts Weigh In

Thu, 09 Jul 2009 04:00:00 GMT

Early Reporting Workers' Injuries Helps both Employee and Companies Control Costs

Thu, 09 Jul 2009 04:00:00 GMT

International Clinical Trials: Look Before You Leap

Mon, 16 Feb 2009 05:00:00 GMT

Traveling Employees and Workers Compensation: Managing International Exposure

Mon, 16 Feb 2009 05:00:00 GMT

Effective Supply Chain Management for Medical Device Shipments

Mon, 16 Feb 2009 05:00:00 GMT

The Basics of Contractual Risk Transfer

Wed, 10 Dec 2008 05:00:00 GMT

Managing Risk in Hired and Non-Owned Automobiles

Wed, 10 Dec 2008 05:00:00 GMT

Case Study: Clinical Trial Litigation

Wed, 10 Dec 2008 05:00:00 GMT

Beyond Insurance - Comprehensive Risk Analysis Through Enterprise Risk Management

Wed, 10 Dec 2008 05:00:00 GMT

The Perfect Storm

Wed, 06 Aug 2008 04:00:00 GMT

Industry Insight: Claims Resolution

Wed, 06 Aug 2008 04:00:00 GMT

Industry Insight: Claims Resolution Part 2

Wed, 06 Aug 2008 04:00:00 GMT

The Credentialing Morass

Wed, 05 Mar 2008 05:00:00 GMT

Q&A: Certificates of Insurance

Wed, 05 Mar 2008 05:00:00 GMT

Managing Foreign Supply Chains to Avoid Importing Risk

Tue, 11 Oct 2011 04:00:00 GMT

Clinial Trial Insurance - Comparing the Coverage Alternatives

Mon, 24 Oct 2011 04:00:00 GMT

“I’ve had a data breach! Am I at risk?” Understanding Cyber Liability for Technology Companies

Wed, 28 Dec 2011 05:00:00 GMT

Best Practices for Responding to Form-483s and Warning Letters

Tue, 20 Dec 2011 05:00:00 GMT

Preemption Defense for Generic Pharmaceutical Companies

Tue, 13 Dec 2011 05:00:00 GMT

Why Distributors May Be More Vulnerable to Products Liability than They Realize

Wed, 07 Mar 2012 05:00:00 GMT

Selecting Employee Witnesses

Tue, 07 Jun 2011 04:00:00 GMT

Why is the Discovery Process So Expensive?

Tue, 26 Apr 2011 04:00:00 GMT

Preserving Products Involved in Adverse Events

Tue, 29 Mar 2011 04:00:00 GMT

Key Health Policy Lawmakers in the 112th Congress

Mon, 17 Jan 2011 05:00:00 GMT

Sales Representatives and Adverse Events Question #2

Sun, 28 Nov 2010 05:00:00 GMT

Sales Representatives and Adverse Events

Fri, 01 Oct 2010 04:00:00 GMT

If a Lawsuit is Filed

Mon, 19 Apr 2010 04:00:00 GMT

Warning Letters & Products Liability

Thu, 25 Feb 2010 05:00:00 GMT

Do Distributors Require Professional Liability Insurance?

Wed, 31 Aug 2011 04:00:00 GMT

Responding to FDA-483s and Warning Letters

Wed, 28 Sep 2011 04:00:00 GMT

Learned Intermediary Doctrine

Thu, 20 Oct 2011 04:00:00 GMT

Mensing and its Impact

Tue, 15 Nov 2011 05:00:00 GMT

FDA Prosecution under the Park Doctrine

Thu, 26 Jan 2012 05:00:00 GMT

Sales Reps and the "Practice of Medicine"

Wed, 22 Feb 2012 05:00:00 GMT

What are design controls and why are they important?

Wed, 28 Mar 2012 04:00:00 GMT

Battle of the Forms and Contracts

Thu, 10 May 2012 04:00:00 GMT

FDA Pilot Program Gives Device Companies One-Year Reprieve from Inspection

Tue, 15 May 2012 10:27:00 GMT

An FDA pilot program launching next month will allow medical-device companies to obtain a one-year reprieve from FDA inspections by obtaining ISO audits and submitting those audit reports to the agency. This program will begin June 5, 2012, and is set to last for two years. The idea behind the progr... (More)

Life Sciences News Roundup, 5/10

Thu, 10 May 2012 09:06:00 GMT

Seven Things to Consider for Your Life Science Company’s Social Media Policy – MedCity News Nanotechnology in Medicine: Huge Potential, but What Are the Risks? – Medical News Today Op-Ed: Clinical Testing for Medical Devices – Europe vs. the United States – MD+DI Device Talk Preparing for a US FD... (More)

New FDA Rules on Clinical Investigators, Sterility Requirements

Mon, 07 May 2012 10:06:00 GMT

Disqualification of a Clinical Investigator Last year the FDA announced a proposed amendment the clinical-trial regulations in 21 CFR parts 312 (Investigational New Drug Application) and 812 (Investigational Device Exemptions) that would alter the parameters for disqualification of a clinical inves... (More)

Life Sciences News Roundup, 5/3

Thu, 03 May 2012 09:02:00 GMT

EMRs should be classified as a medical device to protect patient safety – MedCityNews Medical Device Safety Bill Approved by Senate – FDA Lawyers Blog FDA Enhances Safety Monitoring of Post-Market Drugs – Product Liability Monitor New Audit Form for Medical Device Regulators – IMARC Research FDA... (More)

Life Sciences News Roundup, 4/24

Tue, 24 Apr 2012 15:11:00 GMT

FDA Rips Europe's System for Medical Device Reviews – Qmed Delivering What FDA Expects in Human Factors – MD+DI The Future of Home Healthcare: Searching for Extreme Usability – EMDT With Healthcare Market Challenge Comes Opportunity – MD+DI Wireless Medical Device Hacking – Preventable? – Medica... (More)

California Judge Denies Breadth of Mensing Holding

Thu, 19 Apr 2012 14:12:00 GMT

The seemingly broad holding of last year’s PLIVA, Inc. v. Mensing decision, whereby the Supreme Court held that failure-to-warn claims against manufacturers of generic drugs are preempted by federal law that mandates that generic drugs’ warnings duplicate exactly those of the brand names, has provid... (More)

Life Sciences News Roundup, 4/18

Wed, 18 Apr 2012 11:28:00 GMT

Health Canada Amends Lists of Medical Device Standards – MassDevice Resource: Whitepaper on Determining Significant Risk vs. Non-Significant Risk and IDE Applicability – IMARC Research New Hampshire Quietly Considers Prohibition of Physician Relationships with Medical Device Companies – Life Scien... (More)

Why Life-Sciences Distributors may Be More Vulnerable to Products Liability than They Realize

Mon, 16 Apr 2012 08:47:00 GMT

(Cross-posted on Life Sciences Panorama) Although most life-sciences companies today are likely aware of the increasing threat of products liability lawsuits, this risk is sometimes lost on product distributors, which in actuality may be just as vulnerable as manufacturers to such claims and the fi... (More)

Life Sciences News Roundup, 4/6

Fri, 06 Apr 2012 09:25:00 GMT

Consumer Reports’ Article about Dangerous Devices Is Dangerous Reporting – MD+DI “Fraud-on-the-FDA” Failure to Warn Claims Are Preempted by Federal Law – Sedgwick Pharmaceutical Law Update New Era of Drug Commercialization: Value Beyond Safety and Efficacy – California Institute for Quantitative B... (More)

Recent Case Sheds Light on Reprocessor Liability

Wed, 04 Apr 2012 08:33:00 GMT

The recent pressures to drive down the cost of medical care have given way to a practice of using medical devices (even so-called “single-use devices”) a greater number of times, on a greater number of patients, before disposing of them. To accomplish this, hospitals are increasingly using reprocess... (More)

The Foreign Corrupt Practices Act

Thu, 19 May 2011 04:00:00 GMT

Developing a Medical Device Recall Action Plan

Sun, 21 Feb 2010 05:00:00 GMT

Drafting Informed Consent Forms

Wed, 15 Sep 2010 04:00:00 GMT

FDA Requirements for Informed Consent Forms

Tue, 28 Apr 2009 04:00:00 GMT

Complaint Handling for Medical Device Manufacturers

Wed, 29 Apr 2009 04:00:00 GMT

The Learned Intermediary Doctrine

Tue, 28 Apr 2009 04:00:00 GMT

Spoliation of Evidence

Tue, 25 May 2010 04:00:00 GMT

European Union “CE” Mark

Fri, 26 Feb 2010 05:00:00 GMT

Medical Device Reports (MDRs)

Tue, 28 Apr 2009 04:00:00 GMT

Misbranding

Tue, 28 Apr 2009 04:00:00 GMT

FDA Requirements for Prescription Drug Advertisements

Tue, 28 Apr 2009 04:00:00 GMT

Quality System

Sun, 21 Feb 2010 05:00:00 GMT

Supplier Controls

Sun, 21 Feb 2010 05:00:00 GMT

Vaccine Injury Compensation Program

Tue, 12 Oct 2010 04:00:00 GMT

Defending a Products Liability Lawsuit

Tue, 01 May 2012 04:00:00 GMT

Medmarc Staff

"What Might Injure My Business?" Five Key Areas for the Busy Risk Manager

Tue, 05 Jul 2011 04:00:00 GMT

As many life sciences companies work to innovate and bring their inventions to the commercial market, the challenge of managing business operations risk often gets added to the responsibilities of CFOs, human resources managers, and compliance officers.

Products Liability Risks for Distributors

Thu, 04 Aug 2011 04:00:00 GMT

This webinar will provide an overview of key products liability concepts relevant to life sciences distributors.

Medical Device Recalls

Wed, 01 Jun 2011 04:00:00 GMT

This page contains general information on recalls, including best practices, tips for working with FDA and other regulatory entities, and brand protection.

The Foreign Corrupt Practices Act

Sun, 01 May 2011 04:00:00 GMT

This page contains information on the FCPA. The webinar and podcast feature Carlos Ortiz, an attorney who specializes in FCPA law and compliance.

The Discovery Process

Fri, 01 Apr 2011 04:00:00 GMT

Learn the basics of the discovery process to be more effective in your handling of the important pre-trial litigation process.

Preserving Products Involved in Adverse Events

Tue, 01 Mar 2011 05:00:00 GMT

This page contains information on how to properly preserve and handle products involved in adverse events.

FDA Outlook for 2011

Tue, 01 Feb 2011 05:00:00 GMT

Learn about changes the medical technology and life sciences industry should expect from the FDA in 2011.

Healthcare and the 112th Congress: An Analysis for the Life Sciences Industry

Sat, 01 Jan 2011 05:00:00 GMT

Learn about upcoming federal legislation that may impact the medical technology and life sciences industry in 2011. The webinar and podcast feature Jeffrey J. Kimbell, a lobbyist who represents clients in the life sciences community.

Managing Electronic Discovery and Records Management

Mon, 01 Nov 2010 04:00:00 GMT

The information on this page covers some of the most critical discovery topics facing medical technology and life sciences companies today, including strategies that have been proven to help companies reduce discovery burdens.

Informed Consent: More Than Just a Signature

Fri, 01 Oct 2010 04:00:00 GMT

The information on this page discusses the informed consent process, including the role of the FDA and Institutional Review Boards (IRBs), pitfalls to avoid when drafting and executing informed consent documents and best practice tips.

Conducting Foreign Clinical Trials

Wed, 01 Sep 2010 04:00:00 GMT

This information discusses some of the industry trends and challenges associated with foreign clinical trials.

Social Media and FDA Regulations

Sun, 01 Aug 2010 04:00:00 GMT

The resources on this page contain information on how companies are currently using social media in a manner that is compliant with FDA regulations.

"No Injury" Class Actions and Emerging Medical Monitoring Claims

Thu, 01 Jul 2010 04:00:00 GMT

The resources on this page will deal with "No Injury" Class Actions and Emerging Medical Monitoring Claims in depth and discuss whether exposure to a known harmful substance is sufficient, by itself, to constitute bodily injury.

Managing the Risk of Off-Label Promotion

Sat, 26 Sep 2009 04:00:00 GMT

These materials offer important and timely information about off-label practices, the connection between off-label promotion and products liability and techniques to avoid potential liability resulting from off-label promotion.

Non-Manufacturer Sellers of Medical Products

Sun, 30 Aug 2009 04:00:00 GMT

Who are non-manufacturer sellers-distributors and how are they set up? Why does the plaintiff sue the non-manufacturer sellers when non-manufacturer sellers do not make the product?

Sales Representatives in the OR: Navigating a Liability Minefield

Fri, 31 Jul 2009 04:00:00 GMT

This information can help your sales force avoid inadvertently creating grounds for products liability claims.

Warnings and Instructions

Sat, 19 Sep 2009 04:00:00 GMT

Medmarc’s Loss Control Team has developed a set of resources that offer information about the products liability risks associated with warnings and instructions and the techniques you can use to minimize those risks.

Pharmacovigilence

Tue, 02 Mar 2010 05:00:00 GMT

These resources contain information about pharmacovigilance and related trends in products liability litigation.

Introduction to the CE Mark

Fri, 26 Mar 2010 04:00:00 GMT

These resources contain information on the CE mark, including what it is, how to get it and how to keep it.

Products Risk and Professional Liability

Fri, 16 Apr 2010 04:00:00 GMT

This webinar helps financial managers/insurance buyers understand and make informed decisions about coverage, risk and premium.

Responding to Form 483s and Warning Letters

Thu, 01 Sep 2011 04:00:00 GMT

Life sciences companies that wish to avoid FDA enforcement actions must be able to respond effectively to FDA-483s and Warning Letters.

Post-Market Requirements for Devices

Tue, 27 Sep 2011 04:00:00 GMT

Companies may not be aware that additional post-market activities not mandated by the FDA may be necessary to mitigate products liability exposures.

Litigation and Claims Trends for the Life Sciences Industry: The 2011 Year In Review and 2012 Forecast

Tue, 01 Nov 2011 04:00:00 GMT

This webinar features Medmarc’s Chief Claims Officer, Cynthia Khin, and Attorney Joseph Thomas, whose practice focuses on the life sciences industry and was involved in the recent Supreme Court case, Pliva, Inc. v. Mensing.

Hot Topics in New and Existing Medical Device Technologies – What is on the horizon from the scientific and legal perspectives?

Wed, 30 Nov 2011 05:00:00 GMT

The medical device landscape is constantly changing as new science and technologies emerge. As the technology changes, so does the potential for liability and lawsuits surrounding the technology.

FDA Enforcement Trends for 2012

Sun, 01 Jan 2012 05:00:00 GMT

Learn what the life sciences industry should expect from the Food and Drug Administration (FDA) in 2012. This webinar will review the regulatory issues and enforcement trends that may impact your operations and bottom line.

Sales Reps in the OR: Avoiding the Products Liability Risks

Fri, 27 Jan 2012 05:00:00 GMT

Sales reps who enter clinical settings, such as operating rooms, often provide invaluable information to medical professionals, yet their presence is fraught with liability perils.

Designing Out Risk: How to Use the Design Process to Manage Risk

Thu, 01 Mar 2012 05:00:00 GMT

Design defects often give rise to costly products liability claims. This webinar will discuss the impact that design controls can have on products liability claims and why design controls matter to the FDA.

Contracts for Life Sciences Companies: The Most Important Risk Management Tool You’re Probably Not Using

Tue, 03 Apr 2012 04:00:00 GMT

Contracts are an essential part of most business relationships, yet life sciences companies frequently fail to contract with important business partners, such as suppliers and distributors.

Foreign Suppliers: Managing the Products Liability Risk in Your Supply Chain

Thu, 26 Apr 2012 04:00:00 GMT

Medical device and drug manufacturers are increasingly doing business with foreign suppliers to locate comparatively inexpensive raw ingredients and component parts...

Introduction

Sat, 21 Jan 2012 05:00:00 GMT

By Kenneth Ross

The Origins of Products Liability

Sun, 05 Feb 2012 05:00:00 GMT

By Kenneth Ross

Manufacturing and Design Defects

Thu, 15 Mar 2012 04:00:00 GMT

By Kenneth Ross

Defects in Warnings and Instructions

Wed, 18 Apr 2012 04:00:00 GMT

Marketing Defects and Warranties

Tue, 15 May 2012 04:00:00 GMT