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The https://www.direnzo.biz podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
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The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
show less
14 NOV 2024 · The Importance of Article 16 of the MDR
Article 16 represents a major advancement in the https://www.direnzo.biz/it/en/parallel-imports-medical-devices/, providing more clarity and detail than previous regulations. Specifically, it:
- Clearly defines what constitutes a parallel import of a medical device.
- Underscores the critical importance of adherence to essential requirements and harmonized standards.
- Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.
- Allows for corrective and safety measures to be taken in the event of non-compliance.
7 NOV 2024 · In this episode, we delve into the crucial role of the https://www.direnzo.biz/it/en/qppv-task-responsibilities/ (QPPV). We'll explore their responsibilities, qualifications, and the importance of their role in ensuring patient safety. From setting up pharmacovigilance systems to managing risk assessments and responding to regulatory inquiries, the QPPV plays a pivotal role in the post-marketing surveillance of medications.
22 JUL 2024 · Welcome to the new Di Renzo Regulatory Affairs podcast!In the ever-evolving landscape of medical device regulation, it is crucial to stay up-to-date. That's why today we'll delve into Regulation (EU) 2023/607, a significant amendment to https://www.direnzo.biz/it/en/mdd-mdr-medical-devices-class-i/ that introduces an extension of the transition period and defines the criteria for benefiting from it.As Regulatory Affairs experts dedicated to Class I medical devices, Di Renzo Regulatory Affairs is ready to support manufacturers in this delicate transition process.In this podcast, we will guide you through the details of Regulation 2023/607, clarifying:
- Which Class I medical devices are eligible for the extension
- How to correctly assess the classification of your device
- What are the specific timelines for the extension
- How to make the most of this additional period to prepare for the MDR
By listening to this podcast, you will gain the knowledge you need to confidently navigate the new regulations and plan a smooth and efficient transition to the MDR.Stay tuned to discover how Di Renzo Regulatory Affairs can support your success in the new medical device regulatory framework!Here are some additional points that you may want to include in your podcast intro:
- Introduce Di Renzo Regulatory Affairs and its expertise in medical device regulation.
- Highlight the importance of the MDR and its impact on Class I medical device manufacturers.
- Emphasize the value of Di Renzo Regulatory Affairs' services in helping manufacturers comply with the MDR.
- Encourage listeners to subscribe to the podcast and leave reviews.
I hope this is helpful!
The https://www.direnzo.biz podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
show more
The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
show less
Information
| Author | Di Renzo Regulatory Affairs |
| Organization | Di Renzo |
| Categories | Entrepreneurship |
| Website | www.direnzo.biz |
| info@direnzo.biz |
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