- 17 December 2021
If you are a Manufacturer
of Medical Devices with a valid certificate issued by a Notified Body under
Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD), you can
place your devices on the market ...
- 28 April 2021
The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation (IVDR) from the point of view of the Manufacturers.
The document ...
- 23 April 2021
The White Paper “Medical Devices Labelling: instructions for use” explains, from the regulatory point of view, what are the labelling requirements for Medical Devices according to the MDR (EU) 2017/745 ...
- 20 May 2020
The following infographic highlights, in chronological order, the scheduled deadlines and the progress of the work with regard to the implementing acts, the measures and initiatives necessary to apply the ...
- 27 April 2020
By reading our White Paper “Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices” you will get detailed information on:
- 23 May 2019
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
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
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;
- 31 August 2018
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
Look at our video to know more about complying with ISO 13485:2016