The dictates of the in vitro diagnostic regulation (IVDR) and “bureaucratic” issues are dampening the industry’s innovation ...
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Registrar Corp purchases Spain’s CMC Medical Devices
Registrar Corp has acquired CMC Medical Devices, a Spain-based company specialising in clinical, regulatory, and compliance ...
What does it take to get into the medical device industry? Sometimes it takes just a pinch of audacity. Lishan Aklog, MD, ...
New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale ...
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...
The global medical device outsourcing market size is projected to reach USD 386.08 billion by 2033, growing at a CAGR of ...
"We're proud to welcome CMC Medical Devices to the Registrar Corp family," said Raj Shah, CEO of Registrar Corp. "Together, we offer medical device manufacturers a single partner to navigate complex ...
In recent years, the in vitro diagnostics (IVD) regulatory landscape in Europe has changed and we are now in the transition from IVD Directive 98/79/EC (IVDD) to In Vitro Medical Devices Regulation ...
The evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...
On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally ...
Germany, France, and the UK lead the IVD market due to robust healthcare systems and government support. Key trends include personalized medicine, digital health, and the adoption of rapid and ...
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