why iso 13485 matters if youre translating medical content

Why ISO 13485 Matters if You're Translating Medical Content

This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry Join Director of Language Services Mike McDermott and Strategic Advisor and Consultant Scott Bass of MadTranslations to learn about the international standard ISO 13485 and why it matters if you are creating content for the medical industry

The Importance of Temperature Monitoring in your Lab

The Importance of Temperature Monitoring in your Lab 2 Proprietary Confidential Agenda Temperature Measurement – Critical to Laboratory Processes Topics: Effects in laboratory – temperature measurement importance Drive to accurate and reliable temperature measurement results Temperature measurement technologies Consistency and Reliability – calibrated and accredited measurement

Working With An ISO 13485 Certified Medical Translator

Issues related to outsourcing and supplier control are at the core of the ISO 13485 standard This is the reason why in 2008 Excel Translations decided to make the necessary investment to become ISO 13485:2003-certified and be an ISO 13485 Certified Medical Translator We continue to maintain this certification today The IOS 13485 standard effectively aligning its quality processes with its clients' in the medical device diagnostic hospital supply

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Dennis Wulf presents: Practical Applications Of ISO 13485

Dennis Wulf presents: Practical Applications Of ISO 13485 And What It Means For HTM Professionals Sponsored by: Innovatus Imaging Wednesday November 20 2019 2:00pm ET PRESENTER: Dennis Wulf Dennis Wulf Founder and CEO of Innovatus Imaging Dennis has more than 35 years of experience working with medical devices specializing in ultrasound He's led successful

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

ISO 13485: What are the six main benefits of QMS

The following is a list of six top reasons to implement ISO 13485 in your company: Improve your company's credibility and image ISO 13485 is the internally recognized gold standard for quality in the medical device industry Certification to this standard shows clients and customers that your company TongWeis quality very seriously and that you have a system in place to ensure it Your

Privacy Matters—Document Translation for Confidential

When you work with a professional document translation company you're entrusting your confidential materials to them for safekeeping during and after the document translation process Not only should they keep them safe but they should also be able to walk you through their process for protecting your company's confidentiality

Notified Body for Medical Devices

LNE/G-MED is a single-source provider of Voluntary and Regulatory certifications and offer complete certification package to save you the time and cost of multiple audits A Single-Source Provider to Serve You Our Clients Say We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip The training was

ISO

ISO 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services It can also be used by internal and external parties such as certification bodies to help them with their auditing processes

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

ISO 13485

Why Implement ISO 13485: 2016 The importance of maintaining the highest quality achievable in the manufacture distribution use and maintenance of medical devices is more vital than with other products and services Product quality issues in the majority of industries may result in widespread recalls substantial financial impact and loss of brand equity Quality problems with

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ISO 13485: Basics and How to Get Started (QMS for

Source In the medical devices industry quality management goes hand-in-hand with safety and both are non-negotiables Requirements like those set out by ISO 13485 are strictly enforced throughout every stage of a medical device's life-cycle including stages after manufacturing like

ISO 13485 Consulting

When you are manufacturing medical devices it becomes even more important Organizations that manufacture medical devices must develop and maintain an extremely robust quality management system The ISO 13485 standard requirements are the foundation upon which to build a robust quality management system It is vital that all of the customer and regulatory requirements be met and

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

The 5 'W's of Quality Agreements

Quality Agreements are required by medical device regulations 21 CFR 820 50 Purchasing Controls as well as various quality standards such as ISO Chapter 7 of the EU GMPs (7 10 through 7 15 [Contracts]) requires a Quality Agreement to define the responsibilities of the contract giver and contract acceptor - Contract manufacture and analysis must be correctly defined agreed and controlled

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

Read School Of Continuing Education Career

School of Continuing Education 2011 - 2012 BMGR 648 Regulatory Affairs for Medical Devices Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry The course will cover U S and European Union (EU) regulations and related agencies Includes laws governing the development manufacturing and approval

Medical Translation Services

As an ISO 9001:2015 and ISO 13485:2016 certified company Stepes delivers the highest level of quality Medical Translation Services including translating IFUs (Information for Use) patient response forms for FDA submissions medical devices manuals and packaging for in-vitro instruments Having translated medical terminology for the world's leading pharmaceutical companies we have the

Guide on Class I (Is/Im) MDD

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