Integrating Swiss MedDO and IvDO into your QMS
Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro…
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IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
Navigating the Current US FDA Medical Device Classification
For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to…
EU MDR Risk Classification: Guide and Case Study
Manufacturers are responsible for determining…
IVDR Clinical Performance Studies: Considerations for EU Approval
In other articles, we have covered considerations for manufacturers about clinical investigations when pursuing CE marking under the…
Australia TGA Approval: Leveraging CE Certification and FDA Clearance
Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for…
Medical Device Vigilance Reporting for Australia TGA Compliance
As in other jurisdictions, the Therapeutic Goods Administration (TGA) has established several requirements related to medical device vigilance reporting…
Medical Device Registration in India
The Central Drug Standard Organization (CDSCO), which falls under the jurisdiction of the Ministry of Health…
FDA Final Guidance on Cybersecurity in Medical Devices
On November 2nd, 2023, the FDA organized a webinar to discuss the recently issued Final Guidance for Medical Device…
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