MDR & IVDR Rolling Plan Infographic
The following infographic highlights, in chronological order, the scheduled deadlines and the progress of the work with regard to the [...]
20 05 2020
20 05 2020
27 04 2020
27 04 2020
Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices
By reading our White Paper "Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical [...]
23 05 2019
23 05 2019
Own Brand Labelling (OBL) of Medical Devices in the European Union: the end of an era?
Read our White Paper "Own Brand Labeling (OBL) of Medical Devices in the European Union: the end of an era?" [...]
30 11 2018
30 11 2018
Nanomaterials: the safety evaluation and risk assessment in Medical Devices
Read our White Paper "Nanomaterials: the safety evaluation and risk assessment in Medical Devices" and get further information on: the biological [...]
28 09 2018
28 09 2018
Design Changes: the Management of Changes before and after a 510(k) Notification
Read our White Paper Design Changes: the Management of Changes before and after a 510(k) Notification and get further information on: what [...]
31 08 2018
31 08 2018
MDSAP: Requirements and Control of “Regulatory” Outsourcing
Read the White Paper "MDSAP: Requirements and Control of "Regulatory" Outsourcing"and get further information on: managing “regulatory” outsourcing processes; Local Representative [...]
02 11 2017
02 11 2017
The Customer satisfaction
Look at our video to know more about the Customer satisfaction. https://www.youtube.com/watch?v=hZ4iMjCg37g Read our White Paper The customer satisfaction and [...]
26 10 2017
26 10 2017
Managing the medical documentation translation
Look at our video to know more about managing the medical documentation translation. https://www.youtube.com/watch?v=B73Oa0npl48&t=4s Read our White Paper Managing the [...]
06 10 2017
06 10 2017
What is ASEAN?
Look at our video to know how much progress has been made towards ASEAN Medical Device Directive. https://www.youtube.com/watch?v=8FJHIWUQCqE Read our [...]
19 08 2017
19 08 2017
Clinical Evaluation of Medical Devices: an integrated approach
Look at our video to have more info about the clinical evaluation according to MEDDEV 2.7/1 rev.4 and to the New [...]
