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Revolutionize Your
Medical Device Production

Efficiently to full compliance in MedTech manufacturing.

Whether you need support in quality management, compliant documentation, or sourcing components – 

SIFo Medical is committed to solving your problems.

 

Let's bring your quality management system to peak performance and secure your supply chain. 

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 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Say goodbye to chaotic paperwork and outdated practices.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

  • Establish Efficient Production Processes

  • Compliant Documentation

  • Reduce Complaint Rates

  • 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.

Medical Device 
Quality Management

Together we'll bring your QMS to peak performance. Get support in:

  • Technical Documentation (MDR 2017/745, ISO 13485, FDA)

  • Process Validation

  • Test Method Validation

  • Product Development

  • Design Control

  • Packaging Validation

  • Risk Management

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Medical Device 
Supplier Management

Benefit from quality expertise and an exclusive network to:​

  • Source materials & components for medical device production

  • Conduct Supplier Audits (ISO 13485 & MDR 2017/745)

  • Handle Supplier Development

A Proven Plan to Succesful
Medical Device Production

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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.

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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.

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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.

 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

"We've always done it this way"-mentality

Methodically (where useful)

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. 

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Or email us at:

office@sifo-medical.com

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