Legal Manufacturer.
We stand behind your product as its manufacturer
We place your medical device or IVD on the market under our name and assume regulatory responsibility.
QMS & PRRC
We have been certified to DIN EN ISO 13485 for more than 20 years and therefore operate a certified quality management system (QMS). It governs all processes from development and production to post-market surveillance – and, on request, for your product too!
You do not need your own person responsible for regulatory compliance (PRRC) under Article 15 MDR – we take on that role for you.
Technical documentation & conformity assessment
We prepare the complete technical documentation for you in accordance with Annexes II and III of the MDR.
We are responsible for conducting and continuously updating the clinical evaluation (Annex XIV) to demonstrate the clinical safety and benefit of your product.
For certain risk classes, a notified body must be involved in the conformity assessment procedure before the CE mark may be affixed – we take care of all of this for you.
Post-market obligations (post-market surveillance)
As the party placing the device on the market, you are obliged to:
Continuously collect and evaluate experience gained with the product on the market.
Serious incidents and field safety corrective actions (FSCA) must be reported to the authorities within strict deadlines (e.g. no later than 15 days) – in Germany to the Federal Institute for Drugs and Medical Devices (BfArM).
You must register as an economic operator in the EUDAMED database, assign a unique device identifier (UDI) and maintain the Basic UDI-DI.
On request, we take care of this for you!
Liability and contractual safeguards (OEM/PLM model)
In the event of personal injury, you are directly liable to the patient under the German Product Liability Act (ProdHaftG), because your name is on the label. As legal manufacturer, we assume this liability for you.
If you buy in a product from an OEM and sell it under your own name (PLM), you need a detailed quality assurance agreement: since the MDR, the OEM must disclose all technical data to you.
As legal manufacturer, we take care of this for you.
Specific and sufficiently high cover for medical devices is essential and often required by regulation or contract. We will be happy to advise you and, on request, assume this liability.
On request, we take on the role of manufacturer and the party placing your product on the market, and assume the liability and the risks – so that you can concentrate on selling your product and on what you enjoy doing.