Sterilization of health-care products 



Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (EN ISO 11737-1)


Sterility (Sterility Assurance Level 10-6)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (EN ISO 11737-2)


Pyrogen & Endotoxin tests

Rabbit pyrogen test

LAL endotoxin test



EN ISO 11135

Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

(suitable for heat/radiation sensitive materials)



EN ISO 11137-1




Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 


EN ISO 11137-2



Radiation - Part 2: Establishing the sterilization dose 

EN ISO 11137-3


Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control 


ISO 17665-1


Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices


ISO/TS 17665-2


Moist heat - Part 2: Guidance on the application of ISO 17665-1


ISO/TS 17665-3


Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization



ISO 11138-1


Biological indicators - Part 1: General requirements

ISO 11138-2


Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes


ISO 11138-3

Biological indicators - Part 3: Biological indicators for moist heat sterilization processes





Temperature and temperature/humidity data-loggers


Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature/humidity data-logger


Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy


Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy


Calibrated at 5-temperature points relative to NIST reference and 5-humidity points. Each measurement is corrected relative to the calibration curve.


Data integrity protection for 21 CFR Part 11 requirement.





Parametric release of sterile products


Parametric release effectively shortens sterilization-cycle time and reduces work-in-process. When process-capability has been shown to remain well within defined specification limits, sterilization-validation documentation allow parametric release of medical devices, without 7 days waiting for growth of biological indicators. 





Contact us to shorten your sterilization-cycle time, and/or to validate your sterilization processes according to applicable standards.




Interim Management & effective Consulting 

Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products


30 years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery,  Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR), STED,  including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Certifications acc. current EN ISO 13485 Quality Management Systems, 


Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management from Design to market  (Risk Analysis & Risk Control), including Artificial Intelligence, &  Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.





VAT-ID / USt-ID: DE295239280

Tübingen, Germany  (Stuttgart area) 

DUNS number 313240073




secure email: A.Hekmat(at)

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat 

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