Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
The Get Well platform is used at more than 70 Veteran Affairs Medical Centers (VAMCs). Now that it is listed on the FedRAMP Marketplace, the Get Well digital patient engagement platform can be contracted by any government agency without additional security vetting required.
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pjr.comPerry Johnson Registrars-Quality Assurance — ISO Registration Company
Perry Johnson Registrars-Quality Assurance — ISO Registration Company