Seminar Nr. 16222
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This course will provide you with information about the current regulatory requirements for microbiological and toxicological quality of Medical Devices. Well-versed speakers from Notified Body, Manufacturer and Quality Laboratory will share their experiences with implementation and validation of suitable test methods, common pitfalls, and the expectations of auditors and customers.
They will share their knowledge in transfer the regulatory requirements in the daily business and how to manage the challenges in the fast developing field of Medical Devices
Since 1996, the requirements for the development, the manufacture and the distribution of Medical Devices in the USA have been laid down in the revised cGMP regulations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections are primarily performed by the FDA.
In Europe, three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directives regulate the medical devices industry. GMP regulations - strictly speaking - are not notified. Instead, harmonised standards, especially ISO 13485, revised in 2016, represent the state-of-the-art in the EU. Inspections are primarily performed by Notified Bodies („New Approach for Product Regulations and Conformity Assessment“).
Statistical data about deficiencies of medical devices do only exist in the USA because of the Freedom of Information Act. For years now, CAPA/Complaint Handling, insufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Audits have been among the Top 10 deviations.
An additional focus of authorities and notified bodies is the microbiological and toxicological safety. This means the requirements for hygienic production, sterilisation appropriate to ISO11137/11135 as well as a suitable method for bioburden sterility testing or endotoxin detection.
A new challenge relating to microbiological and sterilisation safety became the ISO 17664 and which Information must the MD Manufacturer provide now to the customer.
For toxicological and biocompatibility analysis, the ISO 10993 defines some requirements, but a current question will be: “How can I get the data I need” especially for the raw materials and intermediates whilst a medical grade is not really defined.
This course is designed for all people from
Regulatory Requirements on Medical Devices