Biomedical subjects
Publications and source records attributed to M Donawa.
Medical device manufacturers who need contract sterilisation services sometimes lack extensive knowledge of the technical aspects of sterilisation processes. For this reason, they may have problems assessing quality requirements for subcontractor sterilisation services. This article discusses important quality issues that should be considered when selecting a sterilisation subcontractor.
If the United States (US) Food and Drug Administration (FDA) receives the funding that it has requested, it plans to increase inspections of clinical investigation sites both in the US and abroad. This article discusses US clinical investigation requirements and guidance documents that should be reviewed when preparing for FDA clinical site inspections.
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For some time now, the only publicly available compliance programme guidance manual on medical device inspections and administrative and enforcement activities has been a draft document. On 7 February 2001, a final guidance document was issued. This article discusses this document and its importance to non-US medical device manufacturers preparing for FDA facility inspections.
The history of the United States (US) Medical Device Reporting (MDR) Regulation is long and complicated. This has made compliance with the requirements an especially challenging exercise. The publication of a new regulation clarifies some outstanding reporting issues, but not all. Part I of this article includes a chronology of MDR regulations and discusses some requirements that should be of particular interest to non-US companies. Part II will discuss the contents of the new MDR regulation.
Part I of this article discussed the chronology of the United States (US) Medical Device Reporting (MDR) regulations, the suspension of the US Designated Agent requirements, and important considerations concerning reporting responsibilities for non-US manufacturers. This article will discuss the contents of the recently published MDR final rule.
This article discusses the Notified Body recommendations issued by the European Forum of Notified Bodies Medical Devices and its subcommittee, the Notified Bodies Recommendations Group. Most of these recommendations represent more detailed guidance documents than the consensus statements issued by this group, which were discussed in a previous article. Some of the recommendations form the basis of the European-level MEDDEV guidance documents.
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Non-US manufacturers marketing in vitro diagnostic (IVD) products in the United States (US) or planning to do so should be aware of a US Food and Drug Administration (FDA) manufacturing guideline. Although it needs to be updated to include design controls and a few other requirements in the current Quality System Regulation, it provides useful information on FDA's position regarding the manufacture of these products.
In spite of diverse challenges, medical device companies are continuing to design and develop high quality products that significantly benefit patients. They are also succeeding in meeting increasingly stringent regulatory requirements. However, these accomplishments do not guarantee commercial success. The importance of designers considering the needs of purchasers during the design phase is examined.
The ability of governments, official bodies, industry and others to uniformly interpret the European Directives for medical devices will have a profound effect on the success of the European system regulating these products. This is particularly important for Notified Bodies. This article will discuss Notified Body consensus statements. An article in the near future will discuss Notified Body recommendations.
In a remarkably short time, the European regulatory landscape for medical devices has changed dramatically and permanently. The speed of this change will continue to accelerate until a fully matured body of rules is in place. This article will examine the current status of regulations in Europe, and some areas that will need to be addressed in the next century.
Article 21 of the In Vitro Diagnostic (IVD) Directive (98/79/EC) contains several important amendments to the Medical Device (MD) Directive (93/42/EEC). This is generally well known. However, the amendments are not always being kept in mind when discussing the requirements of the MD Directive. This article reviews the more important amendments and suggests that it is time to begin planning for them. The new definition of IVD products is also provided.
In December 2000, the new ISO 9000 quality management system series of standards was published. This represents a significant development for manufacturers marketing medical devices in Europe, who use these standards to demonstrate conformity to the European medical device Directives. This article discusses some issues related to the introduction of these standards in Europe and their use in the CE-marking process.