OUR SERVICES
Quality and Supplier Management are critical topics for medical device manufacturers.
A functioning Quality Management System (QMS) is at the heart of your company's ability to manufacture medical devices safely and efficiently.
However, Supplier Management plays at least as significant a role. You must ensure that your suppliers comply with regulations and deliver raw materials reliably. Time plays an essential role here, as hospitals depend on your products and cannot wait.
Both topics will play a role in our consulting as they go hand-in-hand.
We cover the following topics:
Process Validation
Test Method Validation
Packaging Validation
Design Control
Product Development
Sourcing
Supplier Audit
Supplier Development
Compliant Technical Documentation (MDR 2017/745, FDA, ISO 13485)
You get a complete service package tailored to your needs. Benefit from the knowledge and best practices gained from more than 10 years of experience in the MedTech industry.
You can be sure to be up-to-date with the latest regulations.
In addition, you gain access to a valuable network of reliable suppliers.
We will be happy to advise you in a personal meeting to find out how we can support you. Click on the button below to schedule a 1:1 meeting with your primary contact person Simon Foeger.