Qualitas Professional Services, LLC

06/08/2021

Consider applying for this volunteer opportunity and becoming a more engaged member of the RAPS community.

Nominations are due 18 June.

09/08/2020

There has been a lot of guidance recently on Brexit post-transition plans from the UK perspective. But what if you are in the EU and want to continue selling into the UK? Look for the UK's new campagn directed at EU businesses to prepare for business ater 31 December 2020.

The Government has launched a new campaign to help EU businesses get ready for the end of the transition period on 31 December 2020.

09/02/2020

The UK has left the EU, and the transition period after Brexit comes to an end this year. Check out UK.gov to get the latest guidances or follow us on Facebook and LinkedIn to stay updated on selling products into the UK after the Brexit transition!

Regulating medical devices from 1 January 2021

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:
- CE marking will continue to be used and recognised until 30 June 2023
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
8 months for other Class IIb and all Class IIa devices
12 months for Class I devices
- If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK.

09/01/2020

Looking forward to the 2020 RAPS Convergence! While we will certainly miss seeing everyone in person, we are excited about the new virtual format Regulatory Affairs Professionals Society (RAPS) is using.

Register today and add this session to your calendar:

Transitioning From the Soft Transition: Technical Documentation and UDI
Monday, September 14, 2020
12:00 PM – 1:30 PM EDT

10/08/2019

3 presentations today for RAPS EU MDR Workshop here in Amsterdam. I’m wiped!

09/07/2019

Congratulations and shout-outs to Winnie Lu on their 2-year anniversary! Our businesses share the same building & WL is my go to store for gifts, office decorations, and the often needed “treat me”! 🎊🍾🥂

08/29/2019

Looking forward to turning your undertanding of UDI from grey to pink at the RAPS 2019 Convergence in Philadelphia!!

Come to my 'Global Use of Unique Device Identification (UDI)' session on Tues 24 Sept from 4:00-5:30pm in room 203 A/B.

08/06/2019

RAPS Regulatory Conference – Europe 2020 will provide expansive content designed by European regulatory affairs professionals. We will embrace a broad spectrum of current issues facing medical device, IVD, and medicines regulatory professionals, as well as general subjects that impact all professionals in the healthcare products space.

06/28/2019

Lena Cordie-Bancroft presented at the BSI/AAMI International Standards Conference on Medical Device Standards and Regulations today in London. She had back-to-back sessions on UDI and Labels, Symbols & IFUs.

06/28/2019

Lol this is fitting for the current state of the medical device industry!