Is your Quality Management System already ISO13485 certified? No? Then you are in best hands with us!
We’ll prepare your QM system for ISO13485 certification and support you in the preparation of Notified Body Audits.
May we introduce our Medical Devices Power Team:
👮♀️ “The good cop”: Daniela Ostheim
– Quality Manager with many years of experience in ISO & GMDP QM systems.
– TUV-trained to implement QM systems for Medical Device Manufacturers.
– The quiet center in the certification storm.
🕵️♀️ “The bad cop”: Petra Gruber
– ISO9001 & GDP- Quality Manager & Supplier Auditor.
– TUV-certified internal Auditor & Medical Device Auditor.
– Critical attention to detail without losing sight of the big picture.
👩💼👩💼 “The framework”: Johanna Klocker and Stefanie Fraunschiel
– Rounding out the team with their experience as Managing Directors of medical devices under commercial law.
– Our DREHM PV team also supports us in developing and maintaining effective post-market surveillance systems.
Why ISO13485 – is the MDR not enough? 🤔
Although both sets of regulations have significant overlaps, neither covers the full scope of product certification and approval requirements.
MDR focuses more on user safety, while ISO focuses heavily on product development and related quality management. The perfect blend of both systems – garnished with a viable risk management concept – ensures your successful product launch! 💡
✨ Our specialties for you:
– QM System Gap Analysis & proposed measures
– Self-Inspection Programs
– Supplier Audits
– Risk Management Plans
– Management Review
– Setup and maintenance of PMS programs
We look forward to supporting you with ISO13485 certification!