Medical Devices
Validation and routine monitoring of the production process and sterilization procedures of medical devices.
RegiLabs microbiological laboratory for mainland Europe is located in Ede, the Netherlands and offers you comprehensive support for the development, manufacture and final marketing of your medical device. Of course you can also rely on our knowledge of sterilization services provided by our mother company Isotron. RegiLabs extensive experience in validating sterilization processes, and the knowledge of Isotron provides a unique and valuable combination. The high quality, routine and bespoke microbiological testing services, will ensure a safe product release and continues control over your products. Wherever your business is based, we will ensure your products meet any requirements you may stipulate.
Our microbiological testing and advice services
Please consult RegiLabs for plain microbiological testing but also for expert advice, troubleshooting, brainstorming or method development with regard to microbiological testing. We conduct and validate a full range of tests. We have summarized the key areas.
| Microbiological Services |
Method 1 Validations acc. ISO 11137-2 |
Method VDmax25 Validations acc. ISO 11137-2 for multiple or single production batches |
Accelerated Aging Tests acc. ASTM F1980-07 "Standard guide for accelerated aging of sterile barrier systems for medical devices" |
Routine microbiological laboratory tests, for instance bioburden testing, sterility testing, identification of micro-organisms |
Environmental Monitoring for production and cleanroom locations |
Endotoxin / LAL testing |
For our extensive portfolio list of services and contact overview, please click
here.
| Additional Services |
Consultancy and training |
On-site troubleshooting |
Performing in-house verification experiments by means of Gamma irradiation by our own Gamma sites in the Netherlands, Germany, France or UK |
Support from RegiLabs Chemical / Pharmaceutical lab (Utrecht, the Netherlands) |
Extensive knowledge / Company database |
Logistics Support |
Industry expertise
RegiLabs' location in Ede is ISO 9001 / ISO 13485 / ISO 11137-1 / GMP certified. Furthermore, our facilities in Ede are inspected by the US-FDA.
If you would like further information or have any specific questions, please complete our contact
form.
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