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 as a service provider has been monitoring the recent developments to offer you expert advice tailored to your needs and help you prepare the required approval documents. We support both, newcomers and established companies, paying special attention to the implementation of the relevant requirements, which we have outlined for you below.
MDR (EU) 2017/745
For the EU member states, the transition period for the implementation of the new medical device regulation MDR (EU) 2017/745 has expired on 26 May 2021. Compliance with the new European regulation is a requirement for the CE marking and approval of your medical devices.
As service provider, SCC pilots you through the new regulation, ensuring smooth implementation:
- We offer training in which you learn how to implement the MDR in your company, helping you adopt the required procedures in line with ISO 13485.
- In close collaboration with you, we perform a gap analysis and develop individual concepts aimed at re-establishing conformity.
Requirements for Medical Device Approval
The detailed requirements for medical device approval are defined in numerous standards and guidelines:
Risk assessment of medical devices according to ISO 14971
One of the most important requirement with respect to safety and performance is the assessment of potential risks. Get informed how you can manage an internationally recognized risk management file with our help.
Biological evaluation of medical devices according to ISO 10993
All medical devices, which are intended to be in contact with the human body, need to be evaluated and tested within a risk management process according to ISO 10993-1. Find out how we can support you in the biological evaluation of your medical devices.
Clinical evaluation of medical devices
For CE compliance in the European Union, you need to set forth clinical evidences for medical devices of all risk classes. Take advantage of our experience in literature research and the preparation of a clinical evaluation.
Qualification and validation
Verification, qualification and validation play an important role in development, manufacture and quality control. Find out what you need to consider.
Take advantage of the marketing opportunities in other regions and countries and, with our help, obtain international approval for your products.
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.