Quality Management
Consulting
Quality management
Does your quality management system (QMS) also suffer from interface problems?
Would you like to perform better in the next audit?
Is the evaluation of your suppliers based more on gut feeling than on comprehensible methodology?
Only an efficient QMS ensures loyal customers, motivated employees, and strong products that grow your business.
Benefit from our experience and contact us. We are here to help.
Support
Support in optimizing your QMS
We support you with all questions and tasks relating to quality management for (AI-based) medical devices, IVDs and drug-device combinations worldwide. Through our involvement in ISO TC210/WG1 and our decades of experience, we can support your organization with efficient and regulatory-sound solutions. We will accompany you from the creation of your quality management documentation to the certification of your QMS by your notified body.
We will help you to make your processes as compact and your documentation and quality management system as lean as possible to not only implement regulatory and normative requirements but also to create the necessary objective evidence with reasonable effort. By solving interface problems within your process landscape, we create clear communication paths between different departments, because with lean processes you can improve cooperation and reduce your organizations’ workload. Fewer staff are required for the same amount of work which will save costs and increase employee satisfaction.
Audits & Inspections
At your side during audits and inspections
Our lead auditors are at your side during audits and inspections, support you in correcting findings, and train your employees for future audits, because only those who can work like an auditor will appear confidently in an audit situation. We also carry out internal audits and supplier audits according to ISO 19011 on your behalf.
Services
Our consulting services for you!
- Implementation of a complete QMS or specific processes according to the requirements of 21 CFR 820 QSR / QMSR, ISO 13485 and ISO 9001
- Evaluation of your QMS regarding regulatory and normative requirements (e.g. ISO 13485, 21 CFR 820 QSR / QMSR, MDSAP, EU MDR, EU IVDR)
- Implementing process management for the optimization and further development of existing processes
- Implementation of data lifecycle management for AI-based medical devices
- Implementing systems for unique device identification (UDI)
- Computer system validation (CSV) according to ISO/TR 80002-2 and ISO 13485
- Conducting internal audits and supplier audits according to ISO 19011
- Supporting in establishing statistical process controls (SPC/AQL)
- Training and further qualification of your quality management representative
- Preparation, support and follow-up of FDA inspections and audits by Notified Bodies
- Training at your location or at our academy in Hamburg
Download
Download a wealth of knowledge here
Contact
Contact us
Get in touch with us free of charge to discuss your individual needs and find out more details about our services.
Your direct line to us
Let's work together to strengthen your competitive advantage, broaden your horizons and enter new markets. Click below to get in touch and take the first step.
NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg
+49 40-668-788-199
