Abbreviated 510(k) – When the abbreviation is allowed
Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
DetailsSoftware change: What the FDA expects from you
In a guidance document, the FDA explains how to implement a software change in a regulatory-compliant manner. It describes when you need a new 510(k) submission (Premarket Notification) and when you “only” need to document the changes.
DetailsAccessories for medical devices: Definition and regulatory requirements
What a lot of people understand by accessories is different from the definition of the term in the German Medical Device Act (MPG). This article gives you an overview of the definition of the term, the regulatory requirements, and typical questions.
DetailsUser Interface of Unknown Provenance UOUP
1. Definition of the term UOUP (according to IEC 62366) The IEC 62366-1:2015 (the standard for “Application of usability engineering to medical devices”) introduces the term UOUP and defines it as follows: A UOUP (User interface of unknown provenance) is a user interface or parts of a user interface with an unknown development process for…
DetailsParameterization of software
The parameterization of software – in this context, we can also talk about customizing or configuring software – often leads to discussion, e.g., regarding responsibilities and the differentiation to in-house production. This article gives manufacturers and their customers important advice on what to look out for when parameterizing software and how to avoid the usual pitfalls.
DetailsGuideline IT Security
On November 21, the Johner Institute, together with TÜV SÜD, TÜV Nord, and with the support of Dr. Heidenreich (Siemens), published a guideline on IT security specifically for medical device manufacturers.
Recognized consensus standards of the FDA
The FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsEU General Data Protection Regulation GDPR
The EU General Data Protection Regulation must be complied with starting at 25 May 2018, at the latest. Many companies, amongst them also medical device manufacturer and operators such as hospitals, are not adequately prepared. This article gives you a review of the main concepts and requirements of the General Data Protection Regulation and examines…
DetailsProcess validation: Definition & examples ~ What to look out for
Process validation is the verification that a process meets the requirements imposed on its process results. Learn when you must validate which processes (in the context of software) and how to ace validation. Furthermore, find out what process validation has to do with PQ, IQ, and OQ.
DetailsRetention periods
Medical device manufacturers are obliged to observe and comply with legal retention periods for documents and records. This article provides an overview of the regulatory requirements for the retention periods for the various document classes.
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