Our expert team has at least 10 years of experience in the medical field, device reprocessing, testing equipment, and testing methods.
Welcome To MDS
Your trusted partner from reprocessing validations to regulatory compliance
MDS is a professional laboratory specializing in cleaning, disinfection, and sterilization validation testing. We are dedicated to providing more effective, comprehensive, and safer reprocessing solutions for medical devices.
Comprehensive Validation Services
Cleaning Validation
We specialize in cleaning validation to help you meet stringent regulatory standards and ensure patient safety.
Disinfection Validation
From microbial reduction to process optimization, we ensure your disinfection methods meet the global standards.
Sterilization Validation
Steam sterilization; Low-temperature sterilization; Immersion sterilization
End-of-Life Testing
End-of-life testing and validation for reusable devices
Disinfectant Efficacy
Whether your product is a germicidal spray, wipe, or concentrate, we provide expert support for product testing and verifying labeling claims to ensure compliance and efficacy.
Biofilm
Evaluation and analysis of biofilm formation and removal
Type test for Active Medical Device
At MDS, we offer comprehensive type testing services for active medical devices to ensure they meet rigorous safety and performance
Customized Training
At MDS, we understand that every organization has unique challenges and requirements when it comes to medical device reprocessing.
We are proud to be the partner of choice for many manufacturers worldwide.
Who is MDS
We specialize in providing expert reprocessing validation services to medical device manufacturers worldwide. Our solutions encompass cleaning, disinfection, and sterilization validations, helping ensure compliance with international standards like CE and FDA.
With a team of seasoned professionals, we collaborate with R&D, regulatory, and product management teams to optimize device design, streamline regulatory approvals, and bring safer medical devices to market efficiently.
Our commitment to excellence, innovation, and reliability makes us a trusted partner for advancing global healthcare.
Your Gateway to Reprocessing Excellence
Comprehensive Compliance Solutions
Beyond professional cleaning, disinfection, and sterilization validation services, we serve as your strategic partner, guiding you toward medical device compliance and market success.
Expertise and Tailored Support
With rigorous scientific validations, in-depth regulatory expertise, and customized solutions, we help optimize your product design, accelerate time-to-market, and ensure alignment with international standards.
Professionalism with a Global Perspective
Choosing us means relying on a trusted partner offering professionalism, reliability, and a global outlook to meet your compliance needs effectively.
Comprehensive Validation for Diverse Medical Products
At MDS, we specialise in providing cleaning, disinfection, and sterilisation validation services for a wide range of medical devices and instruments. From flexible endoscopes and dialysis equipment to respiratory and anesthesia devices, our expertise ensures the highest standards of safety and compliance.
Our mission is to ensure the highest standards of safety and efficiency in medical device reprocessing
Through our advanced laboratory capabilities and adherence to global standards such as ISO 17664 and EN ISO 15883, we strive to bridge the gap between regulatory compliance and practical application. Our goal is to not only meet but exceed expectations by offering tailored solutions that address the unique challenges of the medical industry.
Frequently Asked Questions
What standards and regulations do your reprocessing validation services comply with?
We ensure compliance with international standards such as ISO 17664, ISO 15883 series, AAMI TIR12, KRINKO/BfArM Recommendation and regulatory requirements for EU CE marking and FDA approvals.
What types of medical devices do you specialize in for reprocessing validation?
We work with a wide range of reusable medical devices, including surgical instruments, endoscopes, orthopedic, dental, ENT, robotics, contact lenses, personal care, and other devices which requiring cleaning, disinfection and sterilization validations.
How long does it typically take to complete a reprocessing validation project?
The timeline varies depending on the complexity of the device and the scope of testing, but most projects are completed within 4–8 weeks. We also offer expedited services for urgent needs.
Can you assist with both CE marking and FDA submissions?
Yes, we have extensive experience supporting manufacturers in achieving CE marking and FDA clearances. Our team provides tailored guidance to ensure compliance with the specific regulatory requirements of each market.
At MDS, we are a trusted laboratory specializing in cleaning, disinfection, and sterilization validation for medical devices.
Follow Our WeChat Channel
© 2025 MDS Group
