We identify requirements
To ensure that you successfully pass the conformity assessment procedure, we identify the regulatory requirements for your medical device.
Regulatory Affairs
Quality and data protection requirements
Advice on compliance issues
Do you find it impossible to comply with all legal requirements when launching your medical device on the market? We can well understand that. Fortunately, identifying all the requirements for your medical device is exactly what we specialize in.
Simply leave regulatory issues relating to your medical device to us. Regulatory affairs, quality and data protection requirements and advice on compliance issues are all part of our service for you. Because we create your medical device compliance.
How do we create your medical device compliance?
As your legal manufacturer I Full service
As a legal manufacturer, it is our duty to ensure the compliance of your medical device. Can we support you with Legal Manufacturer as a Service? If so, we will take full responsibility for you.
As your consultant I Customized service
What are the specific regulatory requirements for your medical device? We are happy to support you in identifying important areas to ensure compliance.
No matter what you decide. This is how we proceed for medical device compliance:
What medical device compliance means
In principle, compliance goes beyond adherence to all laws by a company, its employees and commissioned third parties (e.g. service providers or consultants).
This is because compliance also includes acting in accordance with voluntary commitments, internal company guidelines and specifications as well as voluntary commitments made by third parties. In other words, everything that gives the product its value above and beyond the minimum legal, contractual and regulatory requirements.
Good to know: Technical documentation according to MDR
Medical device compliance also includes the preparation of technical documentation in accordance with the Medical Device Regulation (MDR). This also includes the preparation of the intended purpose and the risk classification of the medical device.
Check existing documentation
Have you already created technical documentation for a finished medical device? Great, we will be happy to check the documents you have supplied. We will carry out an error analysis and prepare the documents so that you are ready to submit them to your notified body.
Create new
Or do you need support with the creation? We are happy to take care of all communication and scheduling with the notified body for you on request.
TÜV Süd acts as the notified body for us.
Are you looking for a partner to support you in the area of medical device compliance? Or do you need advice from our experts? Simply contact us without obligation and talk to us about your concerns.