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EU MDR and IVDR: unique device identification

The convergence of the pharmaceutical and medical devices industries

Medical device clinical investigations – What’s new under the MDR?

臨床試験の実施というのは、医療機器の製造業者が直面し得る最も時間とリソースを消費する活動のひとつです。このホワイトペーパーでは、欧州のMDRに基づいて実施される市販前及び市販後の臨床試験に関する重要な新しい要求事項について説明しています。

日本語版「医療機器の臨床試験 - MDRにおける変更点」のダウンロードはこちらから >

Responsible persons: The role of the person responsible for regulatory compliance

The MDR and IVDR represent significant changes to European legislation for medical devices and in vitro diagnostic medical devices (IVDs). One significant new requirement is that manufacturers and authorized representatives for both medical devices and IVDs appoint at least one person responsible for regulatory compliance with responsibilities that cover the quality management system (QMS), regulatory documentation, post-market surveillance and vigilance reporting, and devices used for clinical investigation. Download our guide to learn more about the background to the EU rules regarding responsible persons and the actions your organization may need to take as a result of them.

Nanotechnology

Nanotechnology is now a mature subject in terms of the basic science, and while there were many claims for what it could achieve 20 years ago, the application to medicine and healthcare has now become more well defined. When considering nanotechnology's future in the medical devices field, it is best to divide the field into five main categories: medical image enhancement; drug delivery vehicles; nanomaterials for functional coatings; therapeutic aspects of nanomaterials that make use of their small size and properties; and finally biosensors that make use of nanoparticles. There are common themes that apply to each of these fields and in this review we will summarize these and identify gaps in understanding and opportunities.

Responsibilities for medical device vigilance reporting

This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, herein termed ‘vigilance’, in comparison with the requirements of the recently published European Medical Device Regulation (MDR) to support those working with these aspects within the MDSAP Programme. Manufacturers who wish to supply their devices outside of these regions may have many more requirements to meet, the discussion of which is beyond the scope of this paper.

Cybersecurity of medical devices

This paper considers the cybersecurity challenges facing the healthcare sector arising from the convergence of technology, hyper-connectivity and recent developments in regulation. It explains the issues and tensions between safety and security and what can be done to resolve them. The paper highlights emerging good practice and approaches that manufacturers can take to improve medical device security throughout its lifecycle. The paper will also be of interest to others in the sector, including healthcare providers, IT suppliers, notified bodies and regulators.

医療機器サービス

人気のトピック

注目の研修

市場アクセス

ホワイトペーパー

医療機器サービス

人気のトピック

注目の研修

市場アクセス

ホワイトペーパー

EU MDR and IVDR: unique device identification

Phthalates and endocrine disruptors

The convergence of the pharmaceutical and medical devices industries

Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15