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Life Sciences

Q&A: What’s the Impact of New EU Medical Device Regulations (MDR)?

The most sweeping European medical device regulations in decades are slated to go into effect in 2020, leaving many manufacturers wondering what they need to do to get up to speed. Two years may sound like a lot of time to comply, but given the number of changes coming, waiting may not be an option.

We talked to Tony Parise, Life Sciences Product Strategist for EtQ, about what the new requirements mean for medical device manufacturers.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Apr 27, 2018
   
Q&A: What’s the Impact of New EU Medical Device Regulations (MDR)?

The most sweeping European medical device regulations in decades are slated to go into effect in 2020, leaving many...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Apr 27, 2018
Getting Ready for GDPR

Going into effect May 25, 2018, the General Data Protection Regulation (GDPR) represents the most sweeping changes to EU...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Apr 16, 2018
What Are the Changes in ISO 13485:2016?

Transitioning to the New 13485:2016 Standard - Ensuring Compliance

If your organization is one of the more than 59,000...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Apr 06, 2018
3 Things You Need to Know About the MDSAP

Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating...

Alexa Sussman
By Alexa Sussman
on Mon, Mar 26, 2018
4 Ways to Manage Post Market Events in Life Sciences

You have a solid quality system in place for product design, production and testing. Your medical devices pass all tests...

Alexa Sussman
By Alexa Sussman
on Fri, Mar 09, 2018
4 Best Practices for Leading Metrics

The ECA Academy shared that in 2016, most GMP inspection deficiencies involved quality systems—more specifically, the...

Alexa Sussman
By Alexa Sussman
on Mon, Feb 26, 2018
Avoid FDA Warning Letters with These 4 Document Control Best Practices

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures....

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Feb 16, 2018
How a Good Corrective Action Plan Helps You Comply with ISO 13485:2016

ISO 13485:2016, A Review

ISO 13485:2016 is the latest revision of the standards for quality management systems in medical...

Alexa Sussman
By Alexa Sussman
on Fri, Jan 26, 2018

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