GxP Lifeline Newsletter
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February | 2019
MasterControl GxP Lifeline

2019 Med Device Trends to Watch For: Regulatory Changes
by Cindy Fazzi, Staff Writer, MasterControl


For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1. Companies that have been procrastinating are expected to be hit hard.



5 Keys to Helping Your Device Company Gain MDSAP Certification
by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner


Medical Device Single Audit Program (MDSAP) certification serves as a guarantee of the quality of a company's products and gives medical device manufacturers a competitive advantage by opening up large international markets.


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Top 5 Medical Device Industry Trends in 2019
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Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving into 2019
by Grant Bennett, CEO, Brandwood Biomedical


Rapid regulatory change is normal in the emerging (and established) medical device markets of the Asia-Pacific. Substantial changes in 2018 were no exception, including in some cases, whole new regulatory systems rolled out across the region. And 2019 will be offering up more of the “different.”



4 Tips to Improve Your Medical Device Regulatory Submissions
by Cindy Fazzi, Staff Writer, MasterControl


Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.


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