Medical devices demand precision machining, cleanroom production and ISO 13485. Siemens Healthineers (imaging), Dräger (ventilation/anesthesia) and B. Braun (infusion/surgery) lead Germany; MDR 2017/745 is the new EU market regulation.
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Medical
Medical devices demand precision machining, cleanroom production and ISO 13485. Siemens Healthineers, Dräger and B. B...
Medical devices demand precision machining, cleanroom production and ISO 13485. Siemens Healthineers, Dräger and B. Braun lead the German market.
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FAQ
Q MDR vs MDD difference?
A
MDR is stricter: expanded clinical evidence, UDI, PRRC regulatory officer, PSUR post-market surveillance. Transition period closed 2024.
Q Cleanroom classes?
A
Implants ISO Class 7 (10000); general medical Class 8 (100000); IVD reagents Class 5.
Q China-export compliance?
A
NMPA + CE MDR + 510(k) parallel; most products require Notified Body audit.