Libreria

  • 23 May 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?” and immediately learn more about: the OBL (Own Brand Labeling) ...
  • 30 November 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 evaluation nanomaterials-based MD; risk assessment of invasive medical devices; the MDR (EU) 2017/745 ...
  • 28 September 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 is a Design Change; when notifying a Design Change to the FDA; when ...
  • 31 August 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 role and responsibilities; MDSAP five member countries. Fill in the form to receive by ...
  • 11 December 2017

    Complying with ISO 13485:2016

    Look at our video to know more about complying with ISO 13485:2016 https://www.youtube.com/watch?v=wLsJxlHIbP0
  • 11 December 2017

    Objective: Latin America

    Look at our video to know more about Objective:Latin America. https://www.youtube.com/watch?v=a5OnxBWHwo4
  • 11 December 2017

    Medical device market analysis

    Look at our video to know more about the medical device market analysis. https://www.youtube.com/watch?v=xMRjRg9clTA&t=1s
  • 2 November 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 you will understand: the customer’s satisfaction degree; ISO 9001; continuous improvement strategy. Fill in the form ...
  • 26 October 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 medical documentation and you will have more information about: the current regulations according ...
  • 6 October 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 White Paper “What is ASEAN?” and you will have more information about: what ...