Addressing the latest Cybersecurity legislation for medical devices
Many existing medical devices operate on legacy systems, which makes them difficult to maintain and vulnerable to manipulation by hackers.…
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Congenius Whitepaper | Overcoming the challenges of regulating combination products
Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products…
Congenius
MedTech news roundup July 2022
Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…
Congenius
MedTech news roundup June 2022
Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice…
Congenius
MedTech news roundup May 2022
This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal…
Congenius
Leveraging Real-World Evidence in medical device regulatory submissions
Providing data from randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of…
Congenius
MedTech news roundup April 2022
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
Congenius
MedTech news roundup March 2022
This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into…
Congenius