All Quality management system (QMS) articles
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JournalEssential steps for a successful notified body application in medical devices and in vitro diagnostic products
Navigating the notified body (NB) application process is a critical step for manufacturers seeking CE certification for medical devices under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). A well-prepared application can significantly streamline the approval process, reduce delays and ensure compliance with regulatory requirements.
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EditorialThe need for robust quality management
It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...
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JournalPatient information — why do things go wrong?
Are common root causes leading to the pharmaceutical industry being non-compliant with the legal obligation to keep authorised product information up to date?
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JournalQuality management systems — applying good distribution practices to the biopharmaceutical supply chain
Biopharmaceutical supply chain strategies and alignment with good distribution practices (GDPs) are often viewed and planned with a focus on the post-marketing stage. Although this approach is valid, GDP compliance and supply chain strategies have important implications even during the clinical phases of product development. GDP regulations ensure that the integrity of medicinal products is maintained throughout all stages of the supply chain, from the manufacturer’s site to the pharmacy, or person authorised to supply to the public.
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JournalSuccessful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.