Medical Device Posts

Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (more…)

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

electronic Medical Device Reports: 3 Reasons Med Device Manufacturers Should Go Electronic Now

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. (more…)

Will the Medical Device Tax Go over the Fiscal Cliff?

Will the Medical Device Tax Go over the Fiscal Cliff?

Mark Crawford

At the time of this writing the fiscal cliff still looms large—as Republicans and Democrats parry and thrust regarding what gets cuts and what doesn’t, some members of Congress are trying hard to get medical device tax cut from the final spending bill. (more…)

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)

Medical Device Tax Is Three Months Away—Are You Ready?

Medical Device Tax Is Three Months Away—Are You Ready?

 Mark Crawford

Even with the Affordable Care Act (ACA) providing up to 30 million or more Americans with health-insurance coverage (and first-time, affordable access to medical devices), the medical device industry is worried about the looming 2.3-percent medical device excise tax—also a result of the ACA. (more…)

Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)

Sustainability Impacts Medical Devices, Too

Mark Crawford

“Sustainability” has become a trendy, mainstream term over the past decade. However, applying the triple-bottom line aspects of sustainability—economic prosperity, social well-being, and environmental stewardship—is of growing importance to customers, employees, investors, and non-governmental organizations (i.e., stakeholders of manufacturing and institutional organizations). Wayne E. Bates, vice president of Capaccio Environmental Engineering Inc., a comprehensive environmental, health and safety consulting and engineering firm in Marlborough, Massachusetts, discusses how sustainability applies to the medical device community. (more…)

Integrating Risk Management into the Design Process

Mark Crawford

Ron Litke, a senior development engineer with Orchid Design, a division of Orchid Orthopedic Solutions, has over 15 years of design and project management for orthopedics and medical devices. In this brief interview he shares some thoughts about implementing risk management during the design and development process. (more…)

Social Media Can Be a Dangerous Tool

Social Media Can Be a Dangerous Tool

Mark Crawford

It’s not too hard to slip up with social media and get the unwanted attention of the FDA, which is getting serious about policing off-label promotion of products.

With companies scrambling to utilize social media (often without dedicated management), and the confusion that exists about what companies can do legally with off-label promotion, mistakes are going to happen. (more…)

FDA Wants Unique Device Identification System for Medical Devices

Mark Crawford

On July 3 the U.S. Food and Drug Administration proposed that most medical devices distributed in the U.S. must carry a unique device identifier (UDI). The hope is that this system will improve speed of response to adverse events reports, identify and issue target recalls more efficiently, and improve patient safety. (more…)