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Our Services

Ensuring Excellence in Medical Device Reprocessing

With advanced testing capabilities and adherence to global regulations, we provide end-to-end solutions that empower our clients to deliver safer, more effective medical devices. Explore our services to see how MDS can support your commitment to patient safety and regulatory excellence.

Comprehensive Validation Services

At MDS, we offer a comprehensive range of cleaning, disinfection, and sterilization validation services tailored to meet the unique needs of medical device manufacturers and healthcare providers. From ensuring the effectiveness of cleaning protocols to validating disinfection methods and sterilization processes, our expert team is dedicated to upholding the highest standards of safety, compliance, and reliability.

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.

Key Benefits

Tailored validation protocols to meet ISO/FDA standards.

Accelerated timelines for faster market access.

Expert guidance from experienced professionals.

Service Explanation

What you will get?

We deliver comprehensive validation reports, including protocols, testing results, detailed conclusions and customized reprocessing IFU, tailored to meet the specific requirements of regulatory authorities in your target markets.

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Compliant regulations and standards

  • AAMI ST98

  • AAMI TIR12

  • ISO 15883 series

  • ISO 17664 series

  • FDA guidance document

  • AAMI ST79

  • EN 285 series

  • ISO 17664 series

  • ISO 22441 series

  • KRINKO/BfArM Recommendation

Service Process

1

Define Regulatory Goals - Identify your device's reprocessing requirements and regulatory goals (e.g., CE, FDA or NMPA).

2

Specify Intended Use and clinical condition - Describe how device will be used, and any unique feature may impact reprocessing.

3

Determine your method, eg. automated/manual.

4

Estimate and confirm the cost and timeline for the validation process.

5

Tailored testing protocol based on the device intended use, specifications and regulatory needs.

6

Shipping representative devices and cleaning tools (if applicable).

7

Conduct tests as per agreed protocol.

8

Analyze test results to assess compliance with cleaning, disinfection, sterilization validation standards, e.g. protein residue, hemoglobin levels / A0 value, microbial reduction for high-level, intermedia-level, low-level disinfection / SAL level.

What MDS can do for you?

At MDS, your success and satisfaction are our top priorities. Whether you need expert guidance, tailored solutions, or support in navigating complex regulatory requirements, our team is ready to assist.

At MDS, we are a trusted laboratory specializing in cleaning, disinfection, and sterilization validation for medical devices.

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