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Post-Market Surveillance (PMS): Ensuring Compliance Across the EU, UK, and Switzerland Requirements
Executive Summary PMS is a regulatory requirement that systematically monitors a medical device's safety, performance, and quality once it enters the market. PMS processes allow manufacturers to collect real-world data, assess device efficacy, and ensure long-term compliance with regulatory standards. QNET, as your Authorized representative in the EU, UK, and…


	Does have your (potential) AR expert knowledge of European regulatory requirements? i.e. evidence of adequate education, years of experiences, records of continue training as IRCA registered auditor, etc., to demonstrate adequate regulatory competence. Preferable minimum seven years of experiences. Verifiable via IRCA registration dbase. Invalid Input
	Does have your (potential) AR professional clinical and medical expertise? i.e. physicians, M.D., healthcare scientists, who are registered in the national dbase of Ministry of Health in compliance of 2005/36/EC. Verifiable by professional record eg. #GMC, #BIG Invalid Input
	Does have your (potential) AR an word wide coverage of liability indemnity in case of negligence, error and omissions? Verifiable by Certificate of Insurance. Invalid Input
	Does have the your (potential) an additional service to provide Free Sales Certificates (FSC) which are legalized or do have an apostille? Invalid Input
	Does have your (potential) AR an infrastructure to notify and register your products to i.e. NSIS, A.E.M.P.S., ansm, FABDM dbases? Without these registrations it will be difficult to do business in the public sector of specific member state. Invalid Input
	Does have your (potential) AR a service to offer you clinical trial coverage (clinical trial insurance) to protect patients, and medical professionals from adverse events during an RCT caused by an non CE marked medical device? A clinical trial insurance is in many MS mandatory! Invalid Input
	Does have the your (potential) native speaking employees under contract, which may be relevant in communication with National Competent Authorities (NCA). We're able to provide you English, German, French, Dutch, Portuguese, Italian, Polish, and Spanish. Invalid Input
	Does have your (potential) AR an Qualified Person or Responsible Person in their service? Be alert on the specific EU competence requirements! Invalid Input
	Is your (potential) AR adequate ready to support you to be in compliance of the new MDR, IVDR and or ISO 13485:2016? Invalid Input
	(Optional) Is your (potential) AR a member of EAAR? Invalid Input
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