Congenius AG

Tailored MedTech consultancy services in Quality, Regulatory, eHealth, Operations and Clinical, that enable the smartest route to enhanced medical solutions.

[Congenius AG @CongeniusAG]

We finally had the chance to come together and celebrate our 5 year anniversary at a fun-filled cooking event hosted by Mangostan Kochstudio in Zurich. Great to meet in person within a COVID-safe social environment, learn some new recipes and enjoy the fantastic food we created!

[Congenius AG @CongeniusAG]

During #covid, remote solutions for #clinicaltrials became more commonplace. We assess the pros & cons of #decentralizedclinicaltrials, to identify how their mass adoption would change the post-pandemic #clinical landscape...

https://t.co/QNnObuD0cF

[Congenius AG @CongeniusAG]

“FDA registered”, “FDA certified” & “FDA Registration Certificate” do not mean the same as “FDA approved”, “FDA cleared” or “FDA authorised”, even if they appear with the #FDA logo. Our latest #factsheet summarises the differences in this terminology:

https://t.co/FliH7TTIJu

[Congenius AG @CongeniusAG]

Without achieving an updated MRA that met the #MDR deadline last week, Switzerland has now become a third country for the purposes of MDR implementation. We take a look at how this will impact EU-Swiss #medicaldevices trade below...

https://t.co/a3xAI5AlXr

[Congenius AG @CongeniusAG]

Our April #MEDTECH news is now available - get the latest updates and info from the EU Commission, MDCG, FDA, and NMPA from our article below...

https://t.co/wimmafWP09

[Congenius AG @CongeniusAG]

This month marks 5 years of Congenius! A huge thanks to our internal team and valued customers - without your support and collaboration we wouldn't be enjoying this great milestone! #anniversary #team

[Congenius AG @CongeniusAG]

Very excited to be launching our Clinical department, and warmly welcoming Dr Barbara Widmann who will head up the Clinical team! Find out more below... #medicaldevices #clinicalaffairs

https://t.co/Q4Sju4k2JA

[Congenius AG @CongeniusAG]

We've taken a closer look at the #FDA draft guidance on the biocompatibility of #MedicalDevices in contact with intact skin and highlighted 5 key learnings - check out the article here:

https://t.co/8RMUnhLEQH

[Congenius AG @CongeniusAG]

As this especially challenging year draws to a close, our recent two-part topical article focusses on looking to the future - in particular, at what lies ahead for #AI within medical devices...

https://t.co/haLLU3qyVM

[Congenius AG @CongeniusAG]

Need quick-read guidance on #MedTech regulatory submissions? Take a look at our fact sheets on De Novo and 510(k)...

https://t.co/27XUfjBfst

[Congenius AG @CongeniusAG]

Stay informed and up to date with our regular MedTech news round ups - take a look at our November update below...

https://t.co/M5hNJKI9hr

[Congenius AG @CongeniusAG]

Congenius 2.0 has launched! Take a look at our journey towards revitalising our brand identity to take our organisation to the next level...

[Congenius AG @CongeniusAG]

BSI Whitepaper:
Planning for implementation of the European Union MDR
https://t.co/P6LUvvsv9U

[Congenius AG @CongeniusAG]

BSI Whitepaper:
How to prepare for the upcoming MDR
https://t.co/P6LUvvsv9U

[Congenius AG @CongeniusAG]

BSI Whitepaper:
ISO 13485 - The proposed changes and what they mean for you
https://t.co/P6LUvvsv9U

[Congenius AG @CongeniusAG]

BSI Whitepaper: Comaprison between ISO 9001:2015 and ISO 13485:2016
https://t.co/P6LUvvsv9U