Benefit-Risk under MDR 2017/745

Nach einer intensiven Vorbereitung freue ich mich sehr mit der TÜV SÜD Akademie ein neues Seminar starten zu können. Unser Seminar hebt die Nutzen-Risiko-Analyse als Herzstück der Konformitätsbewertung unter der MDR 2017/745 hervor. Obwohl diese Analyse nun als...

Audit hint: impact assessment of changes

Audit hint: Please make sure that you document a proper impact assessment of changes. Especially for design changes you must evaluate, for example, impact to shelf-life, bicompatibility, and sterilization. If you are not able to provide such assessments during the...

MDCG 2023-3 Rev 2

The MDCG Guidance for Vigilance was revised again. Practically, there are no relevant changes for manufacturers. Please note that you „must allow 48 hours (equivalent to two weekdays) for receipt of comment on the draft FSN, unless the nature of the FSCA...

Revalidation of software

Audit hint: Validation of software used within the quality management system as per ISO 13485 is not new and most of the companies did their homework. However, keep in mind that any change to such software must be assessed if revalidation is required. Just recently I...

Medical device recalls in Canada

Changes to Canadian medical device regulation with respect to recalls: get your procedures ready for Dec 17, 2024. Make sure that the revised requirements are implemented. HC offers a nice flowchart guiding along the recall procedure. For voluntary recalls, your...