The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
A quick search of the FDA warning letter database shows more than a dozen entries around 21 CFR 820.72. Calibration is a well-understood...
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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!
Say goodbye to chaotic paperwork and outdated practices.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.
Save Time & Costs
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)
Count On A Reliable Partner
Receive hands-on support, timely results and individual focus on your issues.
Profit from maximum knowledge transfer and count on an exclusive network of quality experts and suppliers, supporting & actively assisting you in all matters relating to quality and supplier management.
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.
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.
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.
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).
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.
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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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!
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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.
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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