Pilot for Software

FDA launched pilot for Software as a Medical Device (SaMD) Precertification program

FDA launched on August 1st a new pilot for Software as a Medical Device (SaMD) Precertification program. US software manufacturers and software manufacturers from abroad can apply for participation. FDA intends to select 9 companies to learn from their best practices of software development. Other software companies will be allowed to provide continuous input. FDA and these 9 companies (large, small, traditional, new entrant, best-in-class, low and high risk) will develop Key Performance Indicators (KPIs) to monitor whether a software manufacturer has a culture of quality and of organizational excellence.

This company culture of quality and organizational excellence needs to provide a safe patient experience; deliver the highest product quality; being clinically responsible; being cybersecurity responsible; and being proactive instead of reactive. By January 2018 FDA will report their findings. This new concept should allow faster market authorization for new innovative SaMDs through a new route of software manufacturer precertification. This precertification would result into a streamlined premarket review and a faster commercial distribution and real-world use. The software manufacturer would collect real-world data to further improve their SaMD.

For MARACA International support with your US authorization of your SaMD contact us  for a discussion and proposal.

Brussels Workshop

MARACA International was at the RAPS EU MDR/IVDR Brussels Workshop 4–5 July 2017.

Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation (MDR) and the new In vitro Diagnostic Device Regulation (IVDR).

MedTech Summit Meeting

MARACA International was at the MedTech Summit Meeting in Amsterdam, The Netherlands, on 19-23 June 2017.

Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation and the new In vitro Diagnostic Device Regulation.

Companion Diagnostics

Dr. Van Hove presented on Companion Diagnostics at the DIA 29th Annual Euromeeting , 29-31 March 2017 in Glasgow,  UK

Dr. Van Hove was asked to share his experience with setting up companion diagnostics projects with pharmaceutical companies and in vitro diagnostic device manufacturer as partners. He highlighted the opportunities and the difficulties with such partnerships. Dr. Van Hove summarized how a successful companion diagnostics partnership could be setup and lead to the successful registrations of the drug and the companion diagnostic device.

European General Data Protection Regulation (GDPR)

On 4 May 2016, the official text of the GDPR Regulation has been published in the EU Official Journal. While the Regulation entered into force on 24 May 2016, it shall apply from 25 May 2018.

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

The Regulation is an essential step to strengthen citizens’ fundamental rights in the digital age and facilitate business by simplifying rules for companies in the Digital Single Market. Violations can cost a company up to 4% of worldwide revenue.  More details can be found here.