With concise documents, assured through the audit and authorization
We ensure that you get your medical product straightly to the market with minimal cost
We show you exactly how to quickly get an authorization for your medical products.Your starter-kit
Do you have a specific question? We would like to help you, for free!More about our free consulting
We assist you in creating documents that will give you an authorization for your products.More about the documents you need
Build a ISO 13485-compliant QM-system to pass the audit easily.Your way to a certificated QM-system
Learn to create a technical documentation. We offer special templates to make this easier for you.Watch more than 70 training videos
Become an expert in software development compliant with: IEC 62304, 62366 and ISO 14971.More about the CPMS seminar
Take advantage of our free products, develop your law-compliant medical products faster and smoothly go through the authorization:
We provide all the knowledge and information you need to create your own technical documentation according to the required standard:
By developing your own competency, you will no longer be dependent on consultants, even on us :-).
If you are in a hurry with your project or have some resources bottleneck, we will guide you individually through your project:
Contact us to discuss further how we could plan your project together and estimate the cost of your project. We are looking forward to hearing from you!
We do (almost) all the work for you, such as creating your complete technical documentation or your QM-handbook including all the descriptions of the process.
We think it is important to also transmit this knowledge to you — and because it is more difficult to achieve in this case —, we recommend this to you only
Contact us now so that we can discuss how we could help you achieve your goals and accurately estimate the cost of your project. We are looking forward to hearing from you!