How the early introduction of a QMS will benefit your start-up
The inception of a MedTech start-up stems from someone having a great idea for a new product that improves therapy…
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Clinical Evaluation under MDR: 5 tips for producing compliant CERs
Following a four-year transition period, MDR finally became fully applicable on 26 May 2021. Since this date, clinical evaluations for…
Congenius
Key learnings from ISO 10993-23:2021: Biological evaluation of medical devices – Tests for irritation
ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation assesses the possible contact hazards from medical…
Congenius
How to connect failure modes and risks in a risk management file
In September we shared an article from our Head of Quality Dr Dirk Hüber on the purpose and methodology differences…
Congenius
Risk Analysis v FMEA: How knowing the difference benefits your risk management
Authorities ask Legal Manufacturers to perform a Risk Analysis for their Medical Devices according to ISO 14971. However, the expectation…
Congenius
The changing landscape for FDA EUAs
An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…
Congenius
Cobalt in medical devices: Do the benefits outweigh the risks?
In 2017, cobalt was up-classified by the European Chemicals Agency (ECHA) with respect to its carcinogenic, reproductive toxicity and mutagenic…
Congenius
Is a decentralized approach the future for clinical trials?
A decentralized clinical trial (DCT) is a trial where subject recruitment, delivery and administration of study medication and collection of…
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