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Feb 5, 2014

The Statistics of Sample Size for Testing to Ensure Regulatory Requirements are Met

Feb 5, 2014|Medical Device Testing, Product Testing, Tips and Advice|

Choosing the optimum number of samples while testing your product boils down to a common trade-off: cost vs. benefit. Staying within your testing budget is important, but ensuring that your data is robust enough to withstand scrutiny from the regulatory body is paramount and can help avoid costly delays due to re-testing. As a contract [...]

Dec 31, 2013

Tips To Make Your Medical Device Testing Project Go More Smoothly in 2014

Dec 31, 2013|Medical Device Testing, Tips, Tips and Advice|

Testing is an essential function for most all medical device companies looking to introduce a product to market. Many medical device manufacturers, however, struggle to understand what they need to do to test and certify their packages and/or products when working with a third-party testing laboratory. Here are some suggested New Year’s Resolutions from DDL for [...]

Aug 29, 2013

Why Are Test Labs Pursuing ISO 17025 Accreditation And Why Is It Important to Medical Device Manufacturers (MDMs)?

Aug 29, 2013|Tips and Advice, Uncategorized|

Medical device contract testing laboratories are seeing more requests from MDMs for regulatory support (performing regulatory testing and maintaining appropriate quality systems – namely, ISO 17025). In an effort to better serve the MDM community many test labs are pursuing ISO 17025 accreditation.  This internationally recognized standard is considered essential for testing facilities around the [...]

Jul 10, 2013

ISO Publishes Revisions to ISO 10555

Jul 10, 2013|Medical Device Testing, Product Testing, Tips, Tips and Advice|

‘International Organization for Standardization’s (ISO) has recently published revisions to all affected parts of ISO 10555 “Intravascular catheters – Sterile and single-use catheters –." ISO 10555 now consists of four parts instead of five and among the important changes are the new tests added for balloon dilation catheters and power injection for flow rate and [...]

Jun 27, 2013

DDL Offers Tip #5 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

Jun 27, 2013|Sustainability, Sustainable Packaging, Tips, Tips and Advice|

#5 - Empower Employees to Drive Sustainability Employees are a powerful asset in the effort to improve sustainable practices.  They are the people who see firsthand the daily practices in the lab space.  Training them to think in a sustainability context will bring forth many unforeseen opportunities for improvement that otherwise may have gone unnoticed.  [...]

Jun 24, 2013

DDL Offers Tip #4 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

Jun 24, 2013|DDL News, Sustainability, Tips, Tips and Advice, Uncategorized|

#4 - Conduct Regular Assessments of Current Practices Information must be collected and analyzed to gain an understanding of current performance in terms of sustainability.  If the company adheres to a standard such as ISO 14001 or has an environmental management system in place, this practice will already be occurring.  But if not, there are [...]

Jun 19, 2013

DDL Offers Tip #3 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

Jun 19, 2013|DDL News, Sustainability, Tips, Tips and Advice, Uncategorized|

#3 - Follow the Three R's Here at DDL, like all packaging labs, we go through a vast amount of packaging material: cardboard boxes, packing peanuts, dunnage, plastic wrap, palates, etc.  Finding ways to reuse any or all of these materials can extend their useful lives and keep them out of landfills.  Reduce: using less [...]

Jun 17, 2013

DDL Offers Tip #2 of “Driving Sustainability: Five Tips for the Packaging and Device Testing Industry”

Jun 17, 2013|DDL News, Sustainability, Testing Services, Tips, Tips and Advice, Uncategorized|

#2 - Limit Climate Variability in Lab Space A major energy consumption driver in any testing facility is the need for climate control.  Tight tolerances on temperature and humidity mean an HVAC system has to work consistently and reliably.  By isolating lab spaces from surround office space and outdoor air, we can minimize the load [...]

Jun 13, 2013

Driving Sustainability: Five Tips for the Packaging and Device Testing Industry from DDL

Jun 13, 2013|Sustainability, Tips, Tips and Advice|

As regulatory bodies and customers alike get on board with the sustainability movement, testing facilities will need to address policies, procedures, and practices to ensure compliance and customer satisfaction.  Often times, this transition is seen as burdensome; an additional task dropped onto and already busy work force with what can be extensive financial implications.  However, [...]

Oct 9, 2012

DDL’s Keys to Collaborative Success with Third-Party Testing Labs

Oct 9, 2012|Medical Device Packaging, Testing Services, Tips and Advice|

In today’s business practices, collaboration is a key component to taking your business to the next level. For many medical device companies, testing is an essential function to introduce a product to market; this often brings these companies to work closely with a third-party testing labs. DDL has been collaborating with medical device companies looking [...]

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