2016 FDA Guidance Documents You Should Know
These were the most important guidance documents of the year for medical device manufacturers.
Oliver-Tolas® Healthcare Packaging & Mangar Medical Packaging announce shared company name, Oliver™
Grand Rapids, Michigan, USA – January 25, 2017 – Oliver-Tolas® Healthcare Packaging and Mangar Medical Packaging joined forces in May of last year and announce today that they will do business as Oliver™. The new name and brand identity preserve the company’s legacy while reflecting its commitment to delivering the highest standards of Quality and Service for innovative healthcare packaging solutions.
Winners and Losers of 2016
Some of these companies, concepts, and technologies came out on top this year, while others took a hit.
Automation, Zero-Defects Philosophy Behind New Drug-Delivery Components Plant
Datwyler Sealing Solutions’s Middletown, DE, facility will produce vial and syringe components when it opens next year.
4 Tips for a Smooth 510(k) Submission Process
As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all Class II devices.
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Medtech trends of the Year
A look back at some of the concepts and ideas that played out in the medical device industry in 2016.
What Volume to Value Means in Medtech
It’s all about data and outcomes these days, top executives at Medtronic, IBM Watson,UnitedHealthGroup, and Mayo Clinic said atAdvaMed on Tuesday.
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Top 7 trends in healthcare packaging
Much more is required of packaging for pharmaceuticals and medical devices these days. In 2016, healthcare packaging professionals managed several emerging regulatory requirements and market demands.
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10 Biggest Medical Device Recalls of 2016
2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.
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Two Big Moves at FDA
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
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