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BSI's Featured White Paper
ISO 13485 and CE Marking
Effective Post-Market Clinical Follow-Up

Dr. Hamish Forster, BSI's Orthopedic & Dental Product Expert, released “The Post-Market Priority,” a white paper that provides a detailed overview of how the recent EU revisions will affect post-market clinical planning and the working relationship with a Notified Body.

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Certification is a Journey, Not Just a Destination

The first step of the certification journey begins with ISO 13485. The standard is an effective solution to meet quality management system (QMS) requirements. Adopting ISO 13485 also provides the foundation needed to meet CE Marking requirements.

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BSI Healthcare Profile
Since 1901, BSI has provided customers with impartial third-party standards-based assurance, compliance, information solutions, and training. BSI is a trusted partner to Industry and Government with over 66,000 organizations, in almost 150 countries, working with over 50 BSI global offices. Our mission is to ensure patient safety while supporting timely access to global medical device technology. We provide thorough, responsive, predictable conformity assessments, evaluations, and certifications that are recognized and accepted worldwide.

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Post-Market Surveillance and Vigilance

Post-market surveillance including clinical follow-up, complaints, and vigilance are vital in ensuring compliance with the EU medical device directives and are an essential component of a 13485 QMS. Learn how to identify the requirements of the European medical device directives, standards, and guidance documents needed to implement an effective post-market surveillance system.

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SmartBrief Archives: Related News
  • FDA issues draft guidance on post-approval drug safety
    The FDA is seeking public comment on guidance detailing a system for handling postmarket drug safety issues, including drug quality and serious adverse events. The draft guidance establishes a three-tiered system of classifying the severity of problems. (U.K.) (3/12)
  • FDA completes guidelines on continuing clinical trial reviews
    The FDA has issued final guidelines on performing continuing reviews to ensure the safety of participants in medical device and drug trials. The guidance, which is based on a proposal issued for public comment in January 2010, also details the type of information that institutional review boards should require from clinical trial sponsors or researchers. Clinica (subscription required) (3/6)
  • FDA issues guidance on submitting electronic trial data
    The FDA has issued guidance on the electronic submission of standardized trial data for medical devices. The document includes guidelines on planning and providing standardized information, terminology, handling data that can't be standardized, validation of data and meetings with the FDA. (Boston) (2/22)
  • Task force seeks comments on IVD device evaluation proposal
    The Global Harmonizaton Task Force has issued proposed guidelines designed to help companies undertake clinical performance evaluations for their in vitro diagnostic devices. The proposal, which includes factors to consider when performing such studies as well as trial design choices based on IVD product types and indications, is up for comment through June 2. Clinica (subscription required) (2/21)
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