Quality Management System Regulation (QMSR) Consulting
A wisely chosen regulatory strategy helps to get the product through "approval" and thus onto the market with minimal costs and as quickly as possible. The Johner Institute is your pilot.
Does the new QMSR present challenges for you?
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.
Our QMSR consulting services
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.
Gap analysisSystematic analysis of your QM system to identify areas for action | QMSR setupDevelopment of a lean, QMSR-compliant QM system | Process optimisationDefinition and adaptation of the required processes |
Document reviewReview of SOPs, work instructions and templates | Education & trainingQualification of your team on normative requirements | CAPA managementPlanning and implementation of corrective and preventive measures |
Audit servicesConducting internal audits and supplier audits | Inspection supportProfessional support during FDA inspections and audits | Templates & ToolsProvision of proven templates and tools |
Your advantages with the Johner Institut
Highest ISO 13485 expertise
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.
On equal footing with auditors
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.
One-stop shopping
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.
Maximum flexibility
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.
Project management included
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.
Solution-oriented
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.
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