What MDR and IVDR confuse and why you should not talk about CAPA. The FDA (in 21 CFR part 820 – QSR) and ISO 13485 differentiate between Unfortunately, the MDR and IVDR do not clearly differentiate between these concepts. Some manufacturers also believe they can combine corrective and preventive actions into one single CAPA process. But…
DetailsDeviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies, 1. Nonconformities: The basics 1.1 Definitions 1.1.1 Nonconformity ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” It equates this term with “error.” ISO 13485 contradicts this. This standard…
DetailsThis article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…
DetailsAn FDA registration is a legally required registration of “establishments” (such as medical device manufacturers) in an FDA database. The FDA registration should not be confused with the UDI registration in the GUDID database or even an FDA approval. This article answers the most important questions and helps to avoid the most common mistakes in FDA registrations.…
DetailsIn this article you will learn, 1. Contents of a declaration of conformity Annex IV of the MDR specifies what a declaration of conformity must contain: 2. Scope of a declaration of conformity Don’t declare conformity for an unspecified number of devices. Wording that doesn’t contain any restrictions in terms of applicability does not comply with…
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…
DetailsClinical affairs managers play an essential role in demonstrating the safety, performance, and benefits of a medical device. They operate at the interface between science and regulation. This article sheds light on the multifaceted role of these experts: tasks and challenges, as well as earning and career opportunities. 1. Tasks of clinical affairs managers Clinical…
DetailsDocument control is a documented procedure that specifies how documents are created, reviewed, approved, labeled, distributed, and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to document control. 1. Subject matter of document control It is obvious that document control is about documents. What is less obvious is what documents are.…
DetailsPDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides 1. PMDS: Functionalities and requirements Patient data management systems (PDMS)…
DetailsCompanies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…
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