Quality management in medical technology balances regulatory compliance and business flexibility. Small and medium-sized companies often lack the time and resources to efficiently maintain a standards-compliant QM system.
This is where our support comes in: as an experienced consulting firm in the field of quality management and regulatory affairs, we accompany you on your way to a lean, audit-proof and practical QM-System.In doing so, we also rely on digital tools such as an electronic quality management system (eQMS) – not as an end in itself, but as meaningful support to implement projects efficiently, transparently and in collaboration with you.
Digital Document Control – Real Added Value in Consulting
Many of our customers continue to work with Word and Excel-based solutions – and that's perfectly fine. However, what makes the difference is how we work together on documents:
An eQMS enables structured document control, in which changes are transparently commented on and versioned. This creates clarity – especially when external partners such as ourselves are involved. Every approval, every response, every comment remains documented and traceable – for everyone involved.
What You Get Out Of It:
- Efficient collaboration with us as your consultants
Working together on Standard Operating Procedures (SOPs), checklists or risk assessments is easy in eQMS without time-consuming file transfers. Comments, Corrections and approvals are bundled centrally in one place – audit-proof and accessible at any time. - Better traceability in projects
Especially in complex QM-processes or MDR-requirements, it is important to maintain an overview. The eQMS helps us to document changes step by step together with you – whether they involve Corrective and Preventive Actions (CAPAs), audits or product files. - Less friction, more structure
Role-based access rights and clearly defined approval workflows ensure that no information is lost and that everyone involved knows what needs to be done and when – even when working across different locations.
QM Consulting that Thinks Ahead – and Grows with You
Our task is not only to guide you through the regulatory jungle, but also to strengthen your internal processes in the long term. That is why we combine specialist knowledge with modern working methods. Whether with or without eQMS, we tailor our services to your needs, but are happy to bring digital solutions into play if they really make your day-to-day work easier.
Do you want to focus on product development without losing sight of quality management? Then get in touch with us – we show you how structured consulting and digital support can go hand in hand.
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