Guide for start-ups – Regulatory Affairs & Design Assurance essentials
Start-ups that want to bring a medical device to market are inevitably confronted with a plethora of questions regarding compliant…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
Cybersecurity for medical devices
Medical devices are often connected to networks and can be vulnerable to cyber-attacks, which can compromise patient safety and the…
Congenius
How will the EU Green Deal impact the medical device industry?
The European Green Deal is a set of policy initiatives on climate action laid out by the EU Commission that…
Congenius
How to choose the right QMS
Whether you’re part of a large, well-established company with an existing Quality Management System, or involved in a start-up that’s…
Congenius
Transferring your manufacturing site | What to consider regarding biocompatibility
Whether for economic or strategic reasons, medical device manufacturers often outsource their production to another site or external company. In…
Congenius
NIS 2 Directive | What it means for healthcare, pharma, and manufacturers of medical devices
On 27 December 2022, Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (NIS…
Congenius
MDCG guidance roundup
As we snap back into action for 2023, here’s a quick roundup of some literature from the MDCG that you…
Congenius
MDR latest | EU Commission calls for urgent amendment
At the EPSCO Council meeting last Friday 9 December, the EU Commission presented a legislative initiative to urgently amend the…
Congenius