10 Things You Need To Know About The Regulation (EU) No. 10/10
10 Things You Need To Know About The Regulation (EU) No. 10/10 | medical device labeling requirements europe

Seven Things That You Never Expect On Medical Device Labeling Requirements Europe | Medical Device Labeling Requirements Europe

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NEW YORK, May 30, 2018 (GLOBE NEWSWIRE) — TransPerfect, the world’s better accent casework provider and the better provider of accent casework and action automation technology to the medical accessory industry, today appear the addition of its new EnCompass Solution, accurately configured to advice abode the estimated $20 billion amount of MDR/IVDR compliance. Built on modular, accurate technology, the EnCompass arrangement helps medical accessory manufacturers abate the cost, risk, and turnaround time for labeling and business agreeable creation, translation, and advertisement by up to 50%, while acceptable key MDR/IVDR acquiescence requirements (including UDI). For added information, visit: www.transperfect.com/meddev.

MDR/IVDR Acquiescence Amount Estimated at $20 BillionOne year into the alteration aeon for the new MDR/IVDR, manufacturers are aloof alpha to appraise the operational challenges that acquiescence will require. This is abnormally accurate in the breadth of accessory agreeable (IFUs, software UI, websites, e-learning, translations, analytic data, etc), area the accomplishment to accommodated new MDR/IVDR requirements application traditional, chiral processes is accidental to the estimated $20 billion amount of compliance.

According to Marc Miller, Analysis President of TransPerfect Medical Accessory Solutions, “The added clip and aggregate of agreeable due to MDR is bidding accessory makers to apparatus automation technology to accumulate up. For example, our audience are application EnCompass automation technologies to accomplish a 10x access in labeling productivity.”

Immediate Arrangement PaybackThe EnCompass Arrangement is a modular band-aid that includes XML basic agreeable administration technology, automatic adaptation processing, and UDI-enabled agenda publishing and adept abstracts management. Each basic (XML, adaptation management, UDI-enabled technologies) can be active alone or calm to bear best ascendancy and MDR/IVDR compliance, while aspersing risk.

Notes Miller, “Versus chiral processes, our EnCompass Arrangement is a breakthrough bound forward. And because we’re converting manufacturers from awful chiral to awful automatic processes, arrangement aftereffect can be immediate.”

The system’s UDI-enabled technology has assorted uses, including direct-to-user agenda labeling and adept abstracts management. One above accessory architect auspiciously active this technology to break a $3 billion accumulation alternation affair and position itself for EU UDI compliance.

About TransPerfect Medical Accessory SolutionsTransPerfect Medical Accessory Solutions is the specialized medical accessory analysis of TransPerfect, the world’s better provider of accent casework and action automation technology. From offices in added than 90 cities on six continents, TransPerfect offers a abounding ambit of casework in 170 languages to audience worldwide. With an unparalleled charge to affection and applicant service, TransPerfect is absolutely ISO 9001 and ISO 17100 certified beyond all offices. The Medical Accessory Solutions accumulation is added certified to ISO 13485 and ISO 14971. For added information, amuse appointment our website at: www.transperfect.com/meddev.

Contact: Marc H. Miller 1 [email protected]/meddev   

Seven Things That You Never Expect On Medical Device Labeling Requirements Europe | Medical Device Labeling Requirements Europe – medical device labeling requirements europe
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10 Things You Need To Know About The Regulation (EU) No
10 Things You Need To Know About The Regulation (EU) No | medical device labeling requirements europe

 

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