A guide to worst-case testing in MedTech
💥 A Meteorite Strikes and the Sky Falls on Us - The Art and Science of Defining Worst-Case Tests in Medical Technology. We believe that...
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Home: Welcome
Supporting MedTech Companies
Comply with Regulatory Requirements.
Secure Your Supply Chain.
Revolutionize Your
Medical Device
Production
Are you overwhelmed by intricate medical device regulations? Stumbling over maintaining quality standards? Frustrated from navigating supplier management issues?
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, manage your suppliers and pass any audit with ease.
Your QMS is the heart of your organization – make sure it is healthy.
Safety
First!
Save Time & Costs
Say goodbye to chaotic paperwork and outdated practices.
Use a proven structured system to build a compliant Quality Management System to produce safe medical devices.
Benefit from our experts' knowledge and experience to make your QMS audit-proof & gain maximum security.
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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 Qualitative Parts & Components at Competitive Prices (up to 70% cost savings)
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Count On A Reliable Partner
Receive hands-on support, timely results and individual focus on your issues.
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Profit from maximum knowledge transfer and count on an exclusive network of quality experts and suppliers supporting and actively assisting you in all matters regarding Quality- and Supplier Management.
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Our mission is your success.
Want to Produce Safe Medical Devices? Invest in Your QMS.
The increasingly stringent requirements in the medical device industry (especially MDR 2017/745) are causing stomachaches to even the biggest players in MedTech. The high bureaucratic effort is time consuming, cost intensiv, and requires specific expertise.
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MedTech requirements often leave room for interpretation and it is not always entirely clear how certain regulations are to be implemented. With unclear specifications and countless guidance papers with different interpretations, it is anything but easy to stay on top of things.
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The consequences of incorrectly implemented regulations in many cases leads to a warning letter.
In worse cases, poor production processes and a weak Quality Management System (QMS) can lead to defective products on the market – the absolute worst case scenario for any medical device manufacturer.
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Investing into your Quality Management System (QMS) should therefore have the highest priority – to minimize risks, establish safe, efficient processes and ultimately comply with regulations.
Quality Management Starts with Your Suppliers.
Quality Management does not start in your own company. It starts with your suppliers, at the very beginning of the supply chain.
Therefore, the MDR 2017/745 also requires your suppliers to comply with certain regulations (see Checklist for Supplier Documentation).
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It is not enough to ask your suppliers to send over an ISO 13485 certificate and believe that they have a good QMS. Unfortunately, there are some charlatans out there who will send you a fake ISO 13485 certificate and disappear from the screen when quality issues appear. So, regular supplier audits are a must – to check if your suppliers practice what they preach.
Remember that the risk and responsibility of your final medical device is yours.
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SIFo Medical supports you with these ever increasing challenges. Count on a reliable partner and hands-on support to fix quality issues, conduct supplier audits, source parts & components, improve your processes and ensure compliance with the latest medical device regulations and standards.
A Proven Plan to Succesful
Medical Device Production
1) Develop a Strategy
Whether you want to build your Quality Management System (QMS) from 0, 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 the 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 an requirements.
3) Finish the Project, Continue with Quality
After a successful cooperation, we will continue to support you whenever you have questions, further projects or recurring tasks like supplier audits & development. Count on a reliable partner by your side.
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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?
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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!
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Book a call.
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We will discuss your questions and the scope of your project.
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You will receive a detailed offer, customized to your needs.
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Everything looks good?
Confirm the order.
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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.
Or email us at:
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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
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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.
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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.
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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.
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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.
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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.
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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.
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