ynlmedtech.com

Yeng & Leong MedTech Consultancy

Yeng & Leong MedTech Consultancy helps companies establish quality management system (QMS) compliant to medical device industry standards and provide guidances necessary for navigating through the global regulatory landscape. We work with our international partners for regulatory, clinical and manufacturing support to provide our clients a comprehensive, one-stop solution so that products are on track to being approved for sale in target markets.

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Yeng & Leong MedTech Consultancy | ynlmedtech.com Reviews

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Yeng & Leong MedTech Consultancy helps companies establish quality management system (QMS) compliant to medical device industry standards and provide guidances necessary for navigating through the global regulatory landscape. We work with our international partners for regulatory, clinical and manufacturing support to provide our clients a comprehensive, one-stop solution so that products are on track to being approved for sale in target markets.

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3 yeng and leong

4 our management

5 our services

6 regulatory strategy

7 qms compliance

8 eqms software

9 product development

10 product registration

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Yeng & Leong MedTech Consultancy | ynlmedtech.com Reviews

https://ynlmedtech.com

Yeng & Leong MedTech Consultancy helps companies establish quality management system (QMS) compliant to medical device industry standards and provide guidances necessary for navigating through the global regulatory landscape. We work with our international partners for regulatory, clinical and manufacturing support to provide our clients a comprehensive, one-stop solution so that products are on track to being approved for sale in target markets.

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ynlmedtech.com

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eQMS Software — Yeng & Leong MedTech Consultancy

http://www.ynlmedtech.com/eqms

Is a cloud based software that simplifies the process for medical device companies to fulfil international regulations, such as ISO 13485 and US FDA 21 CFR, before products are approved for commercialisation. Conventionally, such work is performed manually and is very time-consuming. Stendard is the first to help small businesses achieve compliance in a fast, convenient, scalable and affordable manner. Read next: Design and development of your medical device. Contact us for free consultation today!

2

Production & Manufacturing | MedTech Consultancy | Medical Devices | Singapore — Yeng & Leong MedTech Consultancy

http://www.ynlmedtech.com/device-manufacturing

We have manufacturing partners who are able to assist in prototyping and/or contract manufacturing of your medical device. In the case where your company have your preferred manufacturers, we can help you audit and evaluate their capabilities on your behalf. Looking to setup your own manufacturing facility instead? Click the link below to find out more about Yeng and Leong Geomatic Services and how the technology can improve your life! Yeng and Leong Geomatic Services.

3

What has been included in the new ISO 13485:2016? — Yeng & Leong MedTech Consultancy

http://www.ynlmedtech.com/blog/2016/8/10/iso13485

August 10, 2016. What has been included in the new ISO 13485:2016? August 10, 2016. What has been included in the new ISO 13485:2016? August 10, 2016. This is a guest post by Dr. Michael Rinck, founder and managing director of. The International Organisation for Standardisation (ISO) released its long-awaited revision to the ISO 13485. This global standard for medical device quality management systems (QMS), is replacing the previous ISO 13485:2003. Who is meant to comply to the defined requirements?

4

Quality Management System | MedTech Consultancy | ISO 13485 | Singapore — Yeng & Leong MedTech Consultancy

http://www.ynlmedtech.com/quality-management-system

QUALITY MANAGEMENT SYSTEM COMPLIANCE. From design, manufacturing and distribution to post-marketing activities, a well-established Quality Management System (QMS) is key to all medical device stakeholders, especially in today's medical device industry. QMS Setup - ISO 13485 and FDA QSR. Internal and Supplier audit. Supplier audit must also be performed, especially on your critical suppliers based on ISO 13485 and US FDA QSR requirements. In this current generation where most companies outsource the d...

5

Why You Can’t Ignore Usability Engineering — Yeng & Leong MedTech Consultancy

http://www.ynlmedtech.com/blog/2016/06/29/why-you-cant-ignore-usability-engineering

June 29, 2016. Why You Can’t Ignore Usability Engineering. June 29, 2016. Why You Can’t Ignore Usability Engineering. June 29, 2016. What is Usability Engineering? Usability engineering is the process of identifying potential hazardous situations with user-device interactions and exploring ways to mitigate it. It focuses on the creation and improvement of user interfaces that keep the eventual medical device easy, effective and safe for use. Both IEC 62366-1:2015 and FDA HF/UE guidance. Poor usability en...

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Partner Program for Medical Device Consultants | greenlight.guru

http://www.greenlight.guru/partners

Webinars, Ebooks and Guides. Deliver Better Results. Land More Clients. Geenlight.guru's Partner Program helps you better provide the exceptional quality, regulatory and product development services your clients expect. Being a medical device consultant is hard. Greenlight.guru can make it easier. Challenging to generate new business. Leverage our industry leading content marketing efforts to increase inbound leads and land more clients. Difficult to prove ROI. Mostly project based work. Visit QServe Gro...

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ynlmedtech.com

Yeng & Leong MedTech Consultancy

Yeng and Leong MedTech Consultancy. Your Partner for Medical Device Development. YENG and LEONG MEDTECH CONSULTANCY. Consistently meeting requirements in today's medical device industry. Send us your enquiries to our team of experts or scroll down for more information about our services. Already know what you need from us? Thank you for subscribing to us! Our MedTech Consultancy Services. GET UPDATED WITH OUR LATEST NEWS. Aug 10, 2016. Aug 10, 2016. What has been included in the new ISO 13485:2016? A pro...

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