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Medical device manufacturers are a demanding group of customers who are subject to strict regulatory requirements and pass these on to their suppliers, especially in the case of outsourced processes. Negotiations and agreements are significantly simplified by a common language and an already functional quality management system, ideally certified according to DIN EN ISO 13485:2016.
The seminar helps the participants to become a competent partner in the regulatory area of the medical technology world for (future) customers. The participants get an overview of the parts of the regulation (EU) 2017/745 that are relevant for suppliers and an insight into how to integrate DIN EN ISO 13485:2016 into your own QMS. Central requirements such as risk management or process validation as well as dealing with planned and unannounced audits by notified bodies as critical suppliers are also discussed.
topic overview
- Regulation (EU) 2017/745 MDR: Requirements for suppliers
- Structure and content of DIN EN ISO 13485:2016
- Outsourced critical process, definitions and consequences
- Fixing of documents and records in the QAA
- Traceability and Identification
- Risk Management FMEA or ISO 14971
- Process and product evidence (verification and validation)
- Supplier audits and (unannounced) Notified Body audits
target group
Current and prospective suppliers of components and services to medical device manufacturers.
previous knowledge
Not mandatory.
KONTAKT:
Online
