Regulation of Medical Devices
Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC is the trusted partner for the regulatory compliance of your medical devices, offering you expert advice tailored to your specific needs and helping you prepare the required approval documents. We pave the way to your market success.
We offer the medical device industry regulatory and strategic solutions specialising in:
- International market access strategies
- Globally compliant quality management systems
- MDR (EU) 2017/745 compliance services
- Risk management in accordance with ISO 14971
- Biological evaluation in line with ISO 10993
- Expert advice on dealing with critical substances
- Clinical evaluation and literature research
- Qualification and validation
Learn the full range of our services in English or German and gain an impression of how we can guide you through the intricacies of medical device regulations and the related requirements.
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Contact Our Experts
Together with you, we develop an implementation strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.