How The EU MDR Changed The Landscape of Process Validation
Spoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation. How the EU MDR...
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Revolutionize Your
Medical Device Production
Don't let stringent regulatory requirements stop you from producing innovative medical devices.
Get support from MedTech Quality Experts to solve your quality issues, comply with MDR 2017/745, source components, manage your suppliers and pass any audit with ease.
Safety First! Comply with Regulations
Say goodbye to chaotic paperwork and outdated practices.
Use a proven structured system to build an excellent Quality Management System.
Benefit from our experts' knowledge and experience to make your QMS audit-proof & comply with the latest MedTech regulations & standards.
Efficient Production & Safe Medical Devices
Save Time & Costs in the long-run by using our best practices to
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Establish Efficient Production Processes
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Compliant Documentation
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Reduce Complaint Rates
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Source Parts & Components at Competitive Prices (up to 70% cost savings)
Count on a
Reliable Partner & Active Support
Get hands-on support, timely results and individual focus on your project.
Profit from maximum knowledge transfer and count on an exclusive network of quality experts and suppliers.
We are going to actively support you in all matters regarding MedTech Quality- and Supplier Management.
Your QMS is the heart of your organization – make sure it is healthy.
A Proven Plan to Succesful
Medical Device Production
1) Develop a Strategy
Whether you want to build your Quality Management System (QMS) from scratch, improve your production processes, update your technical documentation or find MDR compliant suppliers –
in a personal meeting we'll discuss your project & start with a clear roadmap to ensure we reach (y)our goal on time.
2) Let the Quality Game Begin
We'll work on your project and discuss the progress in regular (online) update meetings, customized to your individual needs and requirements.
3) Finish the Project, Continue with Quality
We'll continue to support you whenever you have questions, further projects, or recurring tasks like supplier audits and development. Count on a reliable partner by your side.
References
Succes Stories
Step by Step to
Efficient & Safe Medical Device Production
Are you ready to give your QMS a boost, update your technical documentation to comply with MDR 2017/745 or do you want to source materials & components to produce your medical devices?
Whatever your request might be, we always start off with an initial online meeting to get to know each other in person and clarify any questions you might have.
Schedule your initial consultation today!
01
Book a call.
02
We will discuss your questions and the scope of your project.
03
You will receive a detailed offer, customized to your needs.
04
Everything looks good?
Confirm the order.
05
Let's start the journey.
What you can / cannot expect from SIFo Medical
Hands-on-mentality
Solely document writers
Flexibility in scope & tasks
Rigid
Critical, but practical
Methodically (where useful)
"We've always done it this way"-mentality
Part of your team
Home: Contact
Book an Appointment
Arrange your initial call with our CEO Simon Foeger
to discuss your project and clarify all your questions.
Or email us at:
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