top of page
Online-Seminar TÜV_edited.jpg

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.

Logo_AMI.png
Bildschirmfoto 2022-07-12 um 16.20.16.png
313_main.jpg
Heraeus_logo_logotype.png
LN-Logo-Main-PANTONE.jpg

 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Say goodbye to chaotic paperwork and outdated practices.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

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

Analyzing Graphs_edited.jpg

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.

SIFo_Medical_Audit_4.jpg

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.

Test Tubes_edited.jpg

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. 

SIFo Medical CEO Simon Föger | Quality & Supplier Management Expert

Or email us at:

office@sifo-medical.com

  • How can I book a consultation with SIFo Medical?
    Every cooperation starts with an online meeting. Before we start working together, it is vital to us to get to know you in person, and learn about your company, challenges and concerns. Also, we want to clarify all your questions personally. Head over to our calendar and sign up for your initial consultation: https://calendly.com/sifo_medical/initial-consultation-sifo-medical
  • What are you specialized in?
    We are specialized in the following areas: - Test Method Validation - Process Validation - Packaging Validation - Design Control - Product Development - Supplier Audits - Supplier Development - Sourcing compliant components - Risk Management - Technical Documentation (MDR 2017/745, FDA, ISO 13485)
  • How much is a QM Consultation?
    We are not offering standardized consulting packages. All of our consulting services start with an initial consultation to find out what the status quo is, and which results you expect. Based on the initial consultation, you will receive an individual project plan which will be charged according to the length and complexity of the project. For further information, please contact us directly at office@sifo-medical.com. On a side note: The investment in QM consulting pays off very quickly. Most of our clients move things forward much faster during our cooperation because they benefit from proven best practices and hands-on support. Also, outside input is often worth its weight in gold when you can't see the forest for the trees. Not only do you save time and spare some nerves, but you can also save costs in the long run through fewer complaints, efficient workflows, and full compliance with regulations.
  • Which parts and components does SIFo Medical source?
    We source all kinds of parts and components intended to produce medical devices. You can be sure that the supplier fulfills all requirements as requested by the MDR 2017/745 and further critical regulatory requirements. To give a few examples: currently, we are actively sourcing cables, semiconductors, PCBA (Printed Circuited Board Assemblies), and all kinds of disposables.
  • Where does SIFo Medical source components & materials from?
    Currently, we are mainly sourcing in Asia. However, according to your requirements, we will be happy to find and audit suppliers in other regions as well.
  • How long does it take to source materials & components for the production of medical devices?
    This depends on the complexity of the components. For some customers we were able to source parts within a few days. For others, where the complexity of the product is higher, it might take up to several months. However, through our extensive network we are usually able to find suitable partners for you promptly.
  • Why should I source through SIFo Medical and not directly?
    This is an important question. You might think you can source materials cheaper when you buy directly from the supplier. In some cases, this might be right. However, in all our current cooperations, we found materials at more competitive prices than the customer's current suppliers (in some cases, even 70% cheaper – possible through already established business relationships). Also, you will not have to worry about compliance. We ensure suppliers comply with MDR 2017/745 and provide the relevant documentation (Process Validation, Test Method Validation, First Article Inspection, Audit Reports). Further, you have one reliable contact person (speaking German & English) who ensures your suppliers comply with regulations and conducts supplier audits. In many cases, a cooperation with SIFo proves to be more efficient, saves you time & cost, gives you more flexibility, and reduces your risk of non-compliance.
  • What is the process of a supplier audit?
    Our certified auditors conduct supplier audits acc. to ISO 13485. We will independently plan and implement the audit on-site at your supplier and provide you with the documented audit results.
Subscribe

Subscribe to our e-mail list & stay up-to-date:

Thanks for submitting!

Blog

bottom of page