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WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

Article 86 MDR requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and, when relevant, for each category or group of devices. The MDCG 2022-21 guideline endorsed by the Medical Device Coordination Group (MDCG) provides ideas for manufacturers on how to prepare the PSUR for their Medical Devices.

ASPHALION Q4 2022 HIGHLIGHTS

We have compiled our quarterly highlights in a video for you to have an easy-to-scan summary of our newest insights

ASPHALION DIRECTORS’ TESTIMONIAL VIDEO

Our strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards.

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