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FDA plans to use ISO 13485 for medical devices regulation The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.
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BSI was informed on 21 January 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body is the first in Europe to be designated to the new MDR (EU 2017/745).
Navigate Medical Device Consulting for CE Marking, FDA 510K, ISO 13485 & 21 CFR 820 New EU Medical Device Regulation (MDR) The overall objective of the EU MDR implementation has been to ensure high level of protection of human health and safety.
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Apr 25, 2018 · While it is not required by ISO 13485, nor does the FDA does specify in the CFR that you must audit suppliers, it is a very good idea to audit your critical suppliers. If an auditor or FDA inspector sees evidence that your current purchasing controls are inadequate, performing supplier audits may be forced as a corrective action.
IsoLux has earned a warning letter from the FDA for several procedural failures related to its A/C powered illuminators. The Jan. 8 warning letter follows an inspection of the companys manufacturing facility in Naples, Fla., from Nov. 4 through 6, 2015. In the warning letter, the FDA says IsoLux failed to keep documents related to an investigation for uniformity and homogeneity of its fiber
In conjunction with our partners, Medical Device Purchase develops precision crafted products as we continuously look to grow and advance our product line. All MDP products are manufactured with precision and durability in order to take on the most demanding procedures, and they are FDA approved, CE, and ISO 13485 certified.