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Sent on 06 September 2018Learn 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.
Sent on 30 August 2018GMED North America is coming into force at RAPS 2018 Regulatory Convergence, Book a Meeting Today!
Sent on 16 August 2018Training session, the changes and regulatory requirements of the Transition to ISO 13485:2016 & MDSAP for Medical Device Manufacturers
Sent on 29 June 2018Join us for an intensive 2-day course on the European Medical Device Regulation 2017/745
Sent on 13 June 2018This course is designed for Medical Devices professionals: European Medical Device Regulation 2017/745, Transition to ISO13485:2016 and MDSAP
Sent on 26 April 2018Learn the methodological bases and the necessary technical tools and documentation for
implementing the validation, control and audit of ethylene oxide and radiation sterilization processes
Sent on 26 March 2018The Clinical Performance of a Medical Device, common pitfalls when using the word Performance within the European regulatory framework Sent on 15 December 2017At the close of another year we gratefully pause to
wish you a Warm and Happy Holiday Season.
Sent on 14 November 2017We are pleased to announce that effective December 1st, 2017, LNE / G-MED North America, Inc. Sent on 22 September 2017Learn about the new requirements introduced by the European IVD Regulation with respect to the Quality Management System to the IVD legal manufacturers Sent on 05 September 2017RAPS is the perfect opportunity for our clients to meet and discuss with some of our experts and specialists Sent on 22 August 2017ISO13485 and MDSAP Course, take 15% Off with promotional code, last chance to participate to our Training. Sent on 16 August 2017Poor design of medical devices or user interface can lead to errors, learn about the usability standards, regulation, risk management and european requirements Sent on 11 August 2017This webinar discuss Usability Engineering Process, its link to Risk management and Quality management system and highlights European requirements for Med Dev. Sent on 02 August 2017This 2 day course explores two of the most recent evolutions in the Medical Device Industry Sent on 20 July 2017Examine the European and US regulatory context of medical device cyber security and learn more about the biological risk according to the NF EN ISO 10993-1