GEMARMED offers training on a variety of subjects pertaining to US and European requirements for medical devices. These sessions are designed to be interactive and can be conducted either at client facilities, or at the GEMAR office in Modena. The following topics are currently available, but please contact us if you have specific requirements:
The GEMARMED CEO Primers are designed as short briefing sessions for senior company executives who do not need to understand the full detail of the many regulatory requirements that could affect the company's bottom line and future viability. These 2 to 4 hours packages will, however, provide sufficient information for CEOs to be able to understand the important role they have to play as 'top management' in the context of a certificated quality system and regulated environment, also being aware of the many regulatory requirements and likely costs and timescales associated with dealing medical devices.
  • 510(k) submissions

This session provides practical advice on what constitutes a determination of 'substantial equivalence', identification of 'predicate devices', the difference between the three types of 510(k) submissions (Traditional, Abbreviated and Special), what should be included in each, and how to utilize the FDA 'decision-tree'. It will also cover software validation documentation requirements, and the availability and significance of guidance documents.
  • Medical Device Reporting (MDR) requirements (US 21 CFR 803)

Non-US medical device manufacturers are often unaware of their responsibilities regarding reporting adverse events to FDA under the Medical Device Reporting (MDR) regulation 21 CFR 803. This session will explain what constitutes a reportable event, the regulatory requirements for manufacturer investigation, reporting to FDA, follow-up and record keeping once information on a reportable incident becomes known.
  • Medical Device Corrections and Removals (US 21 CFR 806) 

In addition to US requirements for Medical Device Reports (MDRs), manufacturers also need to understand and comply with 21 CFR 806, covering corrections and removals, often referred to as 'recalls'. This session will explain the regulation, the information required by FDA, reporting timescales, and how it applies to non-US medical device manufacturers.
  • US FDA Medical Device Quality System Inspection: Things To Do Before, During and After an Inspection

The US quality system inspection process differs in significant ways from European quality system audits. Medical device companies need to understand these differences and should be adequately prepared for US facility inspections. This training session provides regulatory information related to the inspection process and activities that should be carried out before, during and after the inspection.
  • US Quality System Regulation (QSR) (US 21 CFR 820)

This session will explain in detail the US requirements for a medical device quality system to be in compliance with regulation 21 CFR 820, the Quality System Regulation (QSR). Not only will the language of the QSR be explored, but practical advice on FDA expectations will be explained. Significant differences from the requirements of ISO 13485 will also be covered.
  • The CE Marking Process

There are a number of routes to obtaining the CE mark, thereby allowing the marketing of medical devices in Europe, depending on the risk classification of the device concerned. This session will identify the various routes available for each class of device, and explain the roles of the manufacturer, Notified Body and Competent Authority. It will also examine current guidelines on issues including combination products and 'own-brand labelling'.
  • Directive 2007/47/EC: Revisions to the Medical Device Directives

The deadline for introduction of changes to manufacturers' operating procedures and technical files to take into account the requirements of MDR 2017/45 from 25 May 2020. Recent surveys have shown that many manufacturers are not yet fully conversant with the revised requirements, and are especially unaware of the impact of changes on clinical data, usability and potential overlap with the Machinery and Personal Protective Equipment (PPE) Directives. This session will examine the most significant changes for manufacturers and provide practical advice on not only how to meet the new requirements, but also give an insight into what Notified Bodies are now expecting.
  • European Medical Device Vigilance Requirements

New guidelines on implementation of the European post-market vigilance system were introduced by the European Commission with the MDR 2017/745, although many manufacturers, especially those based outside of Europe, seem unaware of the detail of the expanded guidance and how it may affect the conformity of their current operating procedures. This session will explore the detail of the new guidance and explain the significance of a number of newly defined terms, providing practical advice on implementation and compliance.
  • European IVD Medical Device Requirements

The European In Vitro Diagnostic Device Regulation (IVDR), 2017/746/EC, contains a number of similarities with the Medical Devices Regulation 2017/745/EC, but also includes many significant differences from the MDR. This session will cover the IVDR requirements, including device categories, conformity assessment routes, harmonised standards, common technical specification (CTSs), labelling/e-labelling, available guidance, device registration, and post-market vigilance.
European and US Requirements for Software Contained in Medical Devices
The inclusion of software in a medical device introduces additional risks to those found in other electronic or non-electrical devices, and regulatory authorities therefore require evidence that software-associated risks have been eliminated or reduced as far as reasonably possible before a device can be allowed on the market. European and US requirements are based on the same principles, but may be interpreted differently during the marketing authorization process. This session examines the regulatory and quality system requirements for software-controlled devices, introduces the relevant standards and guidance documents, and identifies what documentation is required to demonstrate compliance.
Please contact us for details on training concerning the requirements for, and management and monitoring of, regulatory and quality system requirements for medical devices.