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GMED
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Your Global Quality Assessor for Medical Devices
Your Global Quality Assessor for Medical Devices

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GMED North America is at #2018RAPS in Vancouver with a line up of #regulatoryaffairs speakers to share its #medicaldevices knowledge - Stop by our booth 415!
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10/3/18
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Stepping into #MDSAP
Watch our new Webinar Now!
#medicaldevices #certification
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Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on Stepping into an MDSAP audit.

The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch on January 2017 of a fully Operational MDSAP program. The program has it stands is built around a standardized audit and assessment models approach to ensure harmonization of practices amongst Auditing Organizations (AOs) such as LNE/GMED, and meet the expectations of medical device manufacturers looking to leverage the use of their regulatory resources in a unique audit. The Medical Device Single Audit Program (MDSAP) is a regulatory program unique in its ability to facilitate access to the USA, Canada, Brazil, Japan and Australia; offering thus the possibility for companies to be assessed in the course of one single Quality Management System ( QMS) audit for up to 5 regulations at once, a program highly suitable for those selling or planning on selling medical devices into these 5 international jurisdictions.

Stepping into the program when carrying already other regulatory certifications requires from medical device companies to understand not only the approach but the expectations set by the applicable regulations and the concept carried on by the program: from the MDSAP auditing scope to the MDSAP grading system for non-conformities and the duration of the MDSAP audit , everything within the MDSAP format is thought to ensure consistency in introducing a harmonized approach meant to provide a global benefit both on short term goals and longer term goals by IMDRF regulators and benefit patient health and patient access.

Join Dharmendra Thakur, Certification Project Manager and Design Dossier Evaluator at GMED North America, Inc. and learn about the MDSAP concept and audit scope, the MDSAP Audit Model, Audit Task and Criteria and anticipate the expectations on the audit Findings, Certification and Post Audit Timelines. For answers to questions, and more, you can tune to GMED North America’s upcoming free webinar on Stepping into an MDSAP audit.
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4 days training - May 1-4 !
Master Ethylene Oxide and Radiation Sterilization for Medical Devices
Register today:
https://www.eventbrite.com/e/master-ethylene-oxide-and-radiation-sterilization-for-medical-devices-tickets-45535350459
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What does Medical Device Clinical Performance stands for?

From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.

Medical Device Clinical PerformanceDepending on one’s background, the answer is always different. Some will say it refers back to the Clinical Performance of a Medical Device while for others, it means both Clinical and Technical performances.

In this newsletter, we want to discuss the different usage of the word “Performance’; the possible confusions between Performances and Characteristics and highlight the common pitfalls when using the word Performance within the European regulatory framework.

https://lne-america.com/library/news/what-does-medical-device-clinical-performance-stands-for
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Webinar: Elements to be provided during the Evaluation of the Technical Documentation
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Book a Meeting Today! #RAPS2017

The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community.

RAPS is the perfect opportunity to meet with our technical experts and discuss your certification project (CE marking, ISO 13485, MDSAP etc.).
Come join us in our booth (#625) or set up a time to meet with us while at the conference.

Our Regulatory and Technical Experts will be speaking
at the following sessions:

EU Medical Device Regulations, IVD Workshop
Sunday, September 10th, 2017
Dr. Julien Senac, PhD, Certification Project Manager and IVD Product Assessor

Post Market Surveillance expectation, including Post-Market Clinical Follow up
Tuesday, September 12th, 2017
Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality - Lead Auditor

https://lne-america.com/library/news/raps-2017-the-regulatory-convergence
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Register Today and take 15% off !
Promo Code : GMED15

Training session on ISO 13485:2016 : the transition and The Fundamentals of MDSAP

September 13th and 14th, 2017
Silver Spring, MD

This unique training brings the most forward-thinking discussions on ISO 13485:2016 and MDSAP to an intimate gathering of RA/QA professionals, medical devices manufacturers and professionals working in the medical devices area.

https://www.eventbrite.com/e/transition-to-iso-134852016-mdsap-for-medical-device-manufacturers-2-days-course-md-tickets-35464930562
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