Whether you have a medical device or a combination product, we can help you to place your product on the market and ensure its ongoing success by building and maintaining an effective quality management system (QMS) and managing regulatory affairs throughout the complete product lifecycle.
Compliance
Design Control, Risk & Project Management
Each company and each device is unique. Therefore the journey taken to achieve a product approval for your medical device, whether it is a CE mark or an FDA approval, will also be unique.
We understand this and we also know that it is needed to develop a customized regulatory strategy for every company and every device considering each client’s individual needs.
At each step in the development of your medical device, you will gain new information and data that influence and change the subsequent steps. Based on this, your regulatory strategy might transform as well.
We will work with you to integrate any new information into the overall plan. We can also assess and adjust your existing regulatory strategy to optimize the pathway to approval for your medical device.
Documentation
Technical File & Quality Management
Technical Documentation (TD)
Documentation is a basic requirement for all medical device risk classes. It demonstrates compliance with the applicable and relevant legislations, such as the medical device regulation EU/2017/745 (MDR) and the in-vitro diagnostic regulation EU 2017/746 (IVDR).
Consistent and efficient technical documentation helps to obtain the product approval within scheduled time.
We continuously work on our medifiler software platform to improve and accelerate regulatory compliance checks. For our customers, we develop complete technical and regulatory submission files for medical devices.
Quality Management System (QMS)
Adequate quality management is crucial for the development and manufacturing of medical devices in accordance with the statutory regulations. Customers and users expect proof of the quality of a medical product - a QMS creates confidence. We can support with an efficient and transparent implementation of ISO13485 compliant QMS.
Notified Body Interaction
The MDR / IVDR does not only affect manufacturers but also Notified Bodies. Early contact with designated Notified Bodies is key to compete now and in the future in the medical device market.
Engineering
Prototyping, Verification and Design Transfer
During development projects, we support our customers with prototypes, design mockup, jigs & tools and test method development at different stages. When it comes to serial production, we plan and manage design transfer activities for our clients.
Collaboration
Manufacturing and Expert Network
adjutem works closely together with partners when you need a contract manufacturer for your device. Also for access to research facilities or support in clinical trials and evaluations, we have the right contact for you.
