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Medical Device Microbiology Analysis

QA’s medical device microbiology testing strategies go beyond clean

How are you ensuring the biological safety of your medical device?

QA Consulting’s experienced microbiologists evaluate your device’s unique microbiology testing requirements, from concept to validation to regulatory approval and beyond. Let our microbiology consultants create processes that assure cleanliness, regulatory compliance, and patient health and serve as your liaison to a network of microbial testing laboratories.

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The benefits of working with an expert

While it may seem tempting to “go at it alone”, creating microbial evaluation processes for your medical device is a complex endeavor. You’ve used your expertise and experience to create a unique innovation. However, assessing and implementing effective and compliant microbiology testing protocols for your device requires a different skill set. Engaging QA Consulting for this task saves time, eliminates uncertainty, and allows you to focus on your core business.

QA’s Principal Microbiology Consultant, Sallie McLaughlin, has spent over 30 years working with both the medical device industry and the FDA. She is an expert in sterility assurance and monitoring, biocompatibility evaluation, and associated validation processes.

Move forward with confidence with QA Consultants

With experienced microbiologists on staff, QA Consulting utilizes national and international standards to address your device’s unique microbiological requirements. We walk you through every step of the process: from the concept phase, to validation, all the way up until the regulatory approval process.

QA’s microbiology consultants will determine the microbial testing and sterility assurance processes most appropriate to your medical device. We help answer questions like:

  • Does your device benefit from endotoxin, microbial strain identification, or bacteriostasis/fungistasis testing?
  • What sort of environmental and sterility assurance controls do you need for your manufacturing facility?
  • Which microbiology testing vendor is suitable for you?

From there our team will tailor a testing regime for your specific device. This includes connecting you with experts who can perform the actual microbial assessments, reviewing the results, and optimizing the process for you.

Lean into our expertise in medical device microbial testing

When you partner with QA Consulting, our knowledge becomes your knowledge. Our many expert consultants provide a wealth of experience across the quality and regulatory spectrum.

  • Biocompatibility assessments
  • Biological safety evaluations
  • Cleanroom qualification and monitoring — ISO 14644
  • Cleaning validation
  • Sterilization efficacy and validation studies — ISO 17665, ISO 11135, ISO 11137
  • Cleaning and disinfectant studies for reusable devices
  • Monitoring plans for endotoxins and bioburden — ISO 11737-1, ANSI/AAMI ST72:2019

QA Consulting provides strategies for all of these processes and builds them with the flexibility to scale to your business size or growth rate. Our dedication to proper scheduling, documentation, and assessment give you the peace of mind to focus on innovation.

Explore our areas of expertise

Having issues with your current medical device microbiology testing?

Cleaning methods for medical devices are important for evaluating biocompatibility and controlling microbial load prior to sterilization. Proper cleaning processes ensure that contaminants are removed without introducing new contaminants, while leaving the biocompatibility and performance of the device unaffected. If pre-sterilization bioburdens remain stubbornly high or the device performance is adversely affected by your current regime, QA’s microbiology consultants can assess and recommend effective remediation strategies.

Once these new protocols are in place, our testing partners will assess parameters such as manufacturing water quality, environmental bioburden, component part contaminant testing, and aseptic practices during assembly and packaging. Our effective, personalized processes ensure your devices are patient-safe and compliance-ready.

Cleanroom Standard EN 17141:2020 and Biocontamination: What Do You Need to Know?

Develop a microbial testing strategy beyond manufacturing

Medical device microbiology testing can extend beyond the manufacturing stage. Reusable medical devices require valid cleaning, disinfection, sterilization, and reprocessing procedures between patients.

These devices acquire a greater microbial load of potentially pathogenic organisms than newly manufactured items. As a result, stringent reprocessing instructions for use (IFU) are required to prevent any cross-patient contamination in health care facilities.

We will design and develop a testing regime specific to your reusable device and connect you with reliable vendors that can carry it out.

From our clients:

“Personally, I want to thank you a lot for your help throughout this process. With your guidance and expertise, you really pointed us toward the best path to be successful and I am extremely grateful for that. I hope that this was just the first of many projects that we have with QA Consulting.”

– Darren DeMerritt, Director of RA/QA, ReNu Medical

Additional QA Consulting Services

medical device microbiology technician wearing purple gloves and safety glasses does a microbiological evaluation of the organisms in a petri dish
brochure cover

We’ve prepared a brochure that encapsulates our approach, qualifications, and expertise in medical device microbiology testing. It offers a glimpse at the important ways we can help you.

Download the Brochure

Have a specific microbiology testing need?

Our team is available to discuss and advise.

Set up a discovery call!