You are familiar with the previous FDA requirements from 21 CFR Part 820, but what does the new QMSR mean for your company? Harmonisation with ISO 13485 sounds good – but what do you really need to change?
There is a great deal of uncertainty: without precise knowledge of the changes, you risk unnecessary extra work or overlooking critical requirements. Time is of the essence, because the FDA does not tolerate deviations.
In the worst case, you could face FDA warnings, rework or even a marketing ban on your products.
We provide comprehensive support in implementing the FDA's new Quality Management System Regulation (QMSR).
The benefit to you: you achieve QMSR compliance with minimal effort and can simultaneously serve the European market. One QM system, two markets – maximum efficiency.
Systematic analysis of your QM system to identify areas for action
Development of a lean, QMSR-compliant QM system
Definition and adaptation of the required processes
Review of SOPs, work instructions and templates
Qualification of your team on normative requirements
Planning and implementation of corrective and preventive measures
Conducting internal audits and supplier audits
Professional support during FDA inspections and audits
Provision of proven templates and tools
Benefit from our comprehensive experience from hundreds of projects, audits and successful approvals. Our highly trained team knows exactly how to establish lean and tailor-made QM systems that meet both FDA and EU requirements – without unnecessary ballast.
In audits and FDA inspections, we argue on equal footing with the auditors and competently defend your interests. The result: less rework, no regulatory stress and successful inspections. Your products remain on the market.
Whether QMS, risk management, product development or approval – we have the complete expertise for all processes, products and technologies. Clear responsibilities and minimal project overheads guarantee efficient processes without friction losses.
Remote or on-site, ‘do it for you’ or ‘do it with you’, tight or generous schedules – we adapt to your needs. As true caretakers, we remove internal barriers and logistical hurdles. You are never alone, but have a partner at your side.
With our team of over 100 people, we have the capacity to implement projects in the shortest possible time. We take care of the entire project management so that your project runs smoothly. Time and budget plans are adhered to – for minimal internal stress and maximum predictability.
There are no regulatory problems that we cannot solve. Our broad experience from hundreds of customer projects makes us your reliable partner for all regulatory challenges. We always find a way to achieve compliance.
Let's work together to make your QM system future-proof. Contact us for a no-obligation initial consultation.
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We review your management system with a trained external perspective. We help you eliminate any problems we find in a targeted manner. You will then be ready for audits by authorities and notified bodies.
As your external quality management representative (QMR), we handle much of the QM work for you, which gives you continuity and regulatory safety.
We help you to bring your medical and IVD medical devices to market in the USA in just a few months using the 510(k) or De Novo Procedure.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops in the field of quality management are the key.
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