Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.That changed with the European Medical Devices Regulation (MDR) modifications approved by European […]
Changes in the European Medical Devices Regulations now require traceability of Medical Devices
October 9, 2020 by
Watch: Current Realities Reshaping Global Supply Chains for US Medical Device Companies
July 21, 2020 by
Watch a moderated discussion with former Congressman Erik Paulsen regarding the new tensions surrounding the supply chain issues impacted by COVID-19 and how the US government is responding. The global pandemic has revealed an interest to address U.S. healthcare’s reliance on non-domestic suppliers. The risks of this over-reliance came into sharp focus during the build-up of the COVID-19 […]
Are Your Package Validation Requirements Ready for EU MDR?
June 25, 2020 by
The COVID-19 pandemic has affected us all these past few months and presented many new challenges for the medical device industry. For package testing, we have seen delays in getting samples shipped to our laboratories due to interruptions in the supply chain. Many MDMs also were forced to put some projects on hold due to […]
What Mass Testing Means for the Packaging World
June 1, 2020 by
As the world fights the COVID-19 pandemic, the tone in America has shifted since the initial battle cry to “flatten the curve.” The lockdown of schools and non-essential business has passed the 10-week mark and caused a counter-reaction to re-open businesses, states, and the overall economy. Short of a vaccine, many public health officials agree […]
Shelf Boxes: Three Best Practices & Tips
May 8, 2020 by
Written by Brian Nissen, CPP Shelf boxes are an integral and functional component of Medical Device Packaging. It is very important to consider the protection they provide, the ease of use as well as the esthetic appearance of the product. There are many techniques on how to best protect your device and its packaging while maintaining […]
COVID-19 Continues to Impact Medical Device Manufacturing in China
April 20, 2020 by
Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. We can see that in China alone, many medical device companies have manufacturing sites, utilize contract manufacturing sites, and get medical device components. The disruption in this supply chain will impact device companies and can […]
Project in chaos? Don’t Panic!
March 18, 2020 by
Project chaos / crises can be caused by several factors, from a complete breakdown of direction, a lack of performance on key activities, or even misguided leadership. Sometimes it’s outside factors that throw everything into disarray. This last cause may be relevant to our current work environments. There are four key elements of rescuing a project […]
Great opportunities for U.S. Medical Device Companies Abroad
February 25, 2020 by
The U.S. produces the most medical devices, and also consumes the most medical devices in the world. U.S. medical device companies are well positioned and are highly regarded globally for their innovations and high-technology products. Why Expand your Exports • Access to new markets has never been easier • Demand, 70% of purchasing power is outside the […]
Does your person responsible for regulatory compliance meet the required criteria?”
January 16, 2020 by
Article 15 of both the Medical Device Regulations and the In Vitro Medical Device (IVD) Regulations have requirements for appointing a ‘person responsible for regulatory compliance’ (PRRC). Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one PRRC. The Medical Device Coordination Group has recently endorsed and made available guidance on this topic. It should be noted […]
DFU Extended
November 18, 2019 by
Most people have heard the product development term “DFX”, where the “DF” stands for “Design For” and the “X” stands for just about everything, most commonly “M” (Manufacturability), “A” (Assembly), “S” (Serviceability), etc. In this way of thinking, a product designer considers all the processes a device will encounter during its entire lifecycle and adds […]