REGULATORY
AFFAIRS

RISK MANAGEMENT

TECHNICAL DOCUMENTATION

CERTIFICATION SUPPORT

 

RISK MANAGEMENT

The goal of risk management is to ensure the safety of patients, users or third parties throughout the product life cycle. Appropriate risk management (e.g. according to EN ISO 14971) is essential for the approval and safe use of medical devices. We will gladly assist you in creating the risk management file and carry out the risk analysis with you. Together or on behalf of us, we will prepare the documents and evidence necessary for the technical documentation with you.

 

TECHNICAL DOCUMENTATION

For the approval of a medical device, a well-composed technical documentation is absolutely necessary. It is a selection of the most important approval documents to demonstrate safety and performance of your product. We would be pleased to compile the technical documentation of your medical device according to the structure of the "STED" (Summary of Technical Documentation) recognized by authorities. This includes a description of the product, basic requirements, labeling information, design and manufacturing process, risk analysis, product verification and validation, the declaration of conformity and much more.

CERTIFICATION SUPPORT

You want to certify a new, innovative medical device or recertify your existing medical device. Are you unsure about the new requirements concerning the MDR implementation? Or do you just have questions in the current certification process and want an expert to look over your documents and give you feedback?
Then we are the right company!


For the certification of a product of higher class I the approval is accompanied by a notified body. We support your certification team or lead the full process staying directly in contact to your notified body.

 
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