Regulatory affairs leads are confronted with increasing legal requirements and often have too few or already overburdened specialists to implement them. Day-to-day work is usually characterized by deadlocked processes and a lot of bureaucracy. Constantly new tools and external consultants who promise more than they deliver in most cases create even more chaos. All of this not only causes stress but also frustration.
But there are suitable solutions for all these challenges: We take the pressure off executives and help them to achieve important objectives for their area.
Clear agreements and objectives lead to meetings that really make a difference instead of just costing time.
We ensure that your employees know exactly what to do and how to do it. This makes them absolutely invaluable and helps your department and your company shape the future.
We roll up our sleeves and make sure that you achieve your objectives no matter what.
We streamline and automate your processes. That allows your teams to achieve their objectives without overworking, even though there is more and more work to do and new laws and standards are constantly being added.
The regulatory conformity of your devices and processes increases. That means fewer headaches when a review, audit, or product test is due.
When everyone knows the problems, what needs to be done, and where to go, the team and the entire company work together hand in hand.
The change projects that we work on together with companies often last between six and 24 months.
This involves, for example,
combining different management systems, such as the quality management system and the IT security management system.
making workflows more efficient, whether by redesigning processes, digitalizing, harmonizing processes in different company areas, or outsourcing certain business processes to external service providers.
improving regulatory compliance in processes, such as approvals, processing corrective and preventive actions (CAPAs), or vigilance.
First, we work with you to find out precisely what the issue is, who is affected, and where the problems lie. In doing so, we determine the objectives and metrics.
We then consider various solution options with you, including the respective advantages and disadvantages, in order to roughly plan the project processes.
We present these options to your senior management so that they can decide on budgets and resources.
We then plan the project in detail, involve all stakeholders, and consider dependencies on other projects.
In the subsequent implementation phase, we work together to revise the processes, test, train, and gain internal support for these changes. We are happy to take an agile approach.
We jointly evaluate the project's success based on objectives and key performance indicators and perform internal audits to ensure compliance.
Once the project is complete, our experts will continue to be available to answer your questions, make optimizations, and transfer the success to other areas of the company.
We have everything that medical and IVD medical device manufacturers need for these projects: We are large, experienced, respected, ISO 13485-certified, have positive references, and are internationally positioned to implement such projects worldwide successfully. Experience has shown that this also facilitates commissioning by a demanding purchasing department.
Let's find out together how we can take your company forward.
Contact us, and we will plan the first steps in your success story.
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+1 (240) 638 27 09
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