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New Polish Act on medical devices - Part Two - Taylor …
- https://www.taylorwessing.com/en/insights-and-events/insights/2022/04/new-polish-act-on-medical-devices-part-2
- This article is also available in Polish. Part Two of our guide to the Poland’s Act on Medical Devices takes a practical look at the most important detailed regulations …
Medical Device Surface Finishing | REM …
- https://www.remchem.com/industries/medical/
- REM’s ISF ® Process is an isotropic superfinishing process that can polish these demanding component applications …
New Polish Act on medical devices - Part Three - Taylor …
- https://www.taylorwessing.com/en/insights-and-events/insights/2022/05/new-polish-act-on-medical-devices-part-3
- Polish legislation goes further than EU law mandating the application of a reduced 8% VAT rate to almost all medical devices. In recent years, a great deal of …
New Polish Act on medical devices - Taylor Wessing
- https://www.taylorwessing.com/en/insights-and-events/insights/2022/04/new-polish-act-on-medical-devices
- We are currently at the final stages of the legislative process of the new Polish Act on medical devices – last week the bill was submitted to the President. The new regulation is expected to come into force as early as 26 May 2022 and it will substantially change the current framework for doing business on the medical devices market in Poland.
FDA Regulation of HCT/P's Product List
- https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/fda-regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-product-list
- An inspectional tool to assist FDA investigators in distinguishing between the human cells, tissues, and cellular and tissue-based products (HCT/P's) that are regulated by the …
Polish Regulation on Medical Devices: an …
- https://www.regdesk.co/polish-regulation-on-medical-devices-an-overview/
- Jul 7, 2020. The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL), the Polish regulating authority in the sphere of …
MPW
- https://mpw.pl/en
- We encourage the awareness of the Polish technical, technological and production concepts. ... All our centrifuges have the CE mark and are registered as medical …
Class 2 Device Recall Sirius Polish Cemented Stem 34B …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=131997
- Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920: Recalling Firm/ Manufacturer: Biomet, Inc. 56 E Bell Dr …
Safety of Metals and Other Materials Used in Medical Devices
- https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
- The FDA accepted feedback through August 18, 2021 in a public docket FDA-2021-N-0334 . Numerous types of materials, including metals, polymers and …
Class 2 Device Recall Sirius Polish Cemented Stem 34B …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=131996
- Class 2 Device Recall Sirius Polish Cemented Stem 34B. The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for …
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