An experienced partner at your side
In-depth know-how, qualified resources and clear, efficient processes: Those who operate in the medical technology market have the highest requirements in terms of performance. But these demands cannot always be met internally. It’s good to have a partner at your side who is a medtech expert through and through – and who can bring his knowledge to you when you need it.
Expertise on demand
QM and Regulatory Affairs
Quality management in medical technology is challenging. Together we face the regulations you have to fulfill. We accompany you from the first admission-specific questions to the preparation of applications for approval.
Development processes. Transition into series manufacturing. Lifecycle management. Together we find solutions that fit your business.
A whole house full of technology specialists. Whether it’s about hardware, software, mechanics or entire systems – we are happy to advise you in our fields of expertise.
Gather and apply knowledge. Benefit from the experience of others. With mentoring, we help you develop your own competencies.
Regulatory affairs the smart way
The MDR (Medical Device Regulation) sets more than 1,100 requirements that manufacturers have to meet for their medical devices. This is 72 percent more than the expiring MDD (Medical Device Directive). The requirements cover quality management systems, processes, documentation and more. What is needed to meet these requirements on the way to approval? Healthy pragmatism and clever approaches, the courage to implement lean processes and tailor-made solutions. This is how the MDR loses its scary effect and your certificate moves closer to you.
Corscience was one of the first medium-sized companies to undergo MDR audit as early as the beginning of 2021. Our experts share their experience and their entire QM/RA knowledge with you. They are available to advise you and also take over entire task packages – so that you can achieve approval safely and quickly.
- Gap analyses
- Creating and maintaining documents
- For active medical devices of all risk classes
- Gap analyses
- Further development of existing systems
- Implementation of adaptions
- ISO 13485 compliant
- Support and monitoring of audits
- Internal, suppliers, notified bodies
- Developing strategies that facilitate or enable admissions in the first place, such as
Step approvals, Strategies for products with little or no clinical data, Strategies for high-risk products
- Monitoring the milestones
- For CE and FDA approvals
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White paper: Label for medical devices
Small surface, big challenge: Labeling medical devices correctly according to current regulations seems like a science in itself at first glance. Our expert Dr. Senem Ntourmas brings clarity to the loads of terms. Read her white paper to find out what’s important when it comes to packing all the relevant information about a product into a compact space.
Please fill out the form – and save your download with concentrated information about labeling.
Finding a consultant
We definitely know that a good consulting relationship depends on the people who work together. It’s about individual ways of thinking, about experience, about communication. You can absolutely trust our professional expertise. How do you find out whether the chemistry is right? Let us get to know each other. We are looking forward.