Who We Serve: Medical Supplies
Sterile Single-Use Devices
Sterility cannot be confirmed by testing the finished product, so for a sterile single-use device it rests on validated processes and the records showing they stayed in control. Auditors know this and follow the chain from bioburden to sterilization to package integrity. We help sterile device makers find the weak links first.
Standards and Regulations to Know
- ISO 11135Ethylene Oxide Sterilization
- ISO 11137Radiation Sterilization
- ISO 17665Moist Heat Sterilization
- ISO 11737Microbiological Methods for Sterilization
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- ISO 13408Aseptic Processing of Health Care Products
- ISO 14644Cleanrooms and Controlled Environments
- ISO 10993 SeriesBiological Evaluation of Medical Devices
Typical Regulatory Exposure
Sterilization is a process whose result cannot be fully verified by inspecting the product, so it has to be validated and routinely controlled. The standards depend on the method: ISO 11135 for ethylene oxide, ISO 11137 for radiation and ISO 17665 for moist heat. ISO 11737 covers the microbiological methods behind bioburden and sterility testing, and ISO 13408 covers aseptic processing for products that cannot be terminally sterilized.
The environment and the package are part of the same story. ISO 14644 covers cleanroom classification and monitoring, and ISO 11607 covers packaging for terminally sterilized devices, including the validation behind a labeled shelf life. Biological evaluation under the ISO 10993 series has to account for sterilization residuals where the method leaves them.
Many sterile device makers use a contract sterilizer, which moves the work but not the responsibility. Compliance Program 7382.850 treats Outsourcing and Purchasing and Production and Service Provision as separate inspection areas, and they meet at the sterilizer: who owns the validation, who reviews the load records, and who decides when requalification is due.
Where Audits Find Gaps
- 01
Periodic Requalification Overdue
Revalidation, dose audits or periodic reviews were scheduled but slipped, and nobody assessed what the delay meant for product already released.
- 02
Bioburden Recorded but Not Trended
Bioburden results are recorded lot by lot but never trended, so a rising count would go unnoticed until it challenged the sterilization process.
- 03
Cleanroom Excursions Closed Without Impact Review
Environmental monitoring excursions are logged and closed, but the record does not show which product was made during the excursion or why it was acceptable.
- 04
Shelf Life Resting on Old Packaging Data
The labeled shelf life relies on aging and integrity studies for a package that has since changed material, supplier or sealing parameters.
- 05
Sterilizer Load Records Filed Unreviewed
Cycle records arrive from the contract sterilizer and are filed without review against the validated parameters before product release.
- 06
Product Family Additions Undocumented
New products were added to an existing validated family or dose with no documented assessment showing they are no harder to sterilize than the product that was validated.
Relevant Standards and Regulations
- ISO 11135Ethylene Oxide Sterilization
- ISO 11137Radiation Sterilization
- ISO 17665Moist Heat Sterilization
- ISO 11737Microbiological Methods for Sterilization
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- ISO 13408Aseptic Processing of Health Care Products
- ISO 14644Cleanrooms and Controlled Environments
- ISO 10993 SeriesBiological Evaluation of Medical Devices
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
Supplier Audit
Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
Questions
Our sterilization is outsourced. What do auditors expect from us?
They expect you to own the outcome. That means a quality agreement defining responsibilities, your own review of validation reports and routine load records, and a process for deciding when requalification is needed. Audits of the sterilizer belong in your supplier control records.
What usually triggers a sterilization revalidation?
Changes to the product, packaging, load configuration, equipment or process can each call for an assessment, along with the periodic requalification your validation defines. The key record is the documented assessment, whether it ends in revalidation or a justified decision not to.
Do you review cleanroom and environmental monitoring data?
Yes. Upload your monitoring reports and excursion records. The first pass looks for excursions without product impact assessments and trends that were not acted on, and an advisor reviews each one against your own procedures.
Sterile Single-Use Devices
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
