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.
March 22-24 | Congress Center, Basel Meet Asphalion’s team at DIA Europe, 2023!! The event will
The European Medicines Agency (EMA) has issued a new Q&A for marketing authorization holders (MAHs) to clarify timelines regarding identifying individual case safety reports from physical/hard copy local journals.
Asphalion has been featured as one of the 10 Best Healthcare Solution Companies in 2022.
Una representación de expertos de Asphalion acudió anoche a la tradicional cena de Navidad de la Sección
Shall we meet at ISOP22?? The 21st Annual Meeting of the International Society of Pharmacovigilance has just
The 21st Annual Meeting of the International Society of Pharmacovigilance (ISoP 2022) starts next week in Verona
Watch Asphalion´s expert Laura Eder in this practical session delivered as a webinar to provide you with
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