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Welcome to Konmex BIOLabs!

We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices – but not only! We are constantly developing our labs to offer more services for your medical devices:

  • Microbiology and sterility testing
  • Package validation
  • Reprocessing validation
  • Consulting services

In Konmex BioLabs you can also order biological reactivity tests, toxicology, and safety tests of:

Our high standard equipment and qualified personnel let us test efficiently, precisely, and fast. We have passed the Good Laboratory Practice (GLP) certification. Our quality system is fully compliant with ISO 17025:2017. Moreover, we are ISO 13485:2016 certified in terms of medical device prototyping for our Customers. We care about quality and reproducibility of our results.

The wide range of tests conducted here makes the product development process short and cost-effective. Just contact us to talk about your needs!

Konmex BioLabs – a place where curiosity and precision meet cutting-edge technology.

NEWS & EVENTS

One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33.

 One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33. We conduct genotoxicity with both prokaryotic (bacterial strains – AMES method) and eukaryotic test systems (mammalian cell lines – Mouse Lymphoma Assay).  Genotoxicity testing applies to various kinds of medical devices, ranging from […]
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An important part of the products we handle are medical devices, that come to contact with blood (blood paths, circulating blood).

🩸An important part of the products we handle are medical devices, that come to contact with blood (blood paths, circulating blood).📝 For such devices, a dedicated group of tests needs to be performed, described in 10993-4, called hemocompatibility tests. This part of the biocompatibility evaluation process consists of many different parts, among which the most […]
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PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response

☣️ PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response.✅ Pyrogenic responses may be material-mediated, endotoxin-mediated, or mediated by other substances.In accordance with the ISO 10993-11 we commonly conduct two test types:✅LAL (Limus Amebocyte Lisate) test to detected endotoxin-specific factors,✅ Material-mediated pyrogenicity test (Rabbit Pyrogen Test) which has […]
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CERTIFICATES

To ensure high-quality services, our laboratory implemented and maintains internationally recognized quality standards: GLP, ISO 13485 and ISO 17025.

GLP – Quality system implemented by Konmex Biolabs. It defines a set of rules and criteria for studies that are planned, performed and monitored, and their results are recorded, reported and archived. It is possible to trace the course of the study or its complete reconstruction.

ISO 17025 – The quality management standard, implemented to standardize the technical requirements and requirements of management system, intended for research laboratories. The Konmex Biolabs management system is based on the ISO 17025 standard.

ISO 13485 – To guarantee the highest quality of your products, Konmex implemented and maintains an international standard containing requirements for medical device prototyping. We are ready to create a prototype of your product that complies with legal requirements and your expectations.

REFERENCES

Please check some of our Customer reviews below.

I cooperated with Konmex Lab at the turn of 2018/2019 in the field of medical device testing. The laboratory services are of a high standard. I am also satisfied with professional advice and efficient execution of orders.

Jolanta, Poland

Cooperation with Konmex was quick and successful in every case. The company provides services reliably, taking care of every detail, and thus the whole topic. The attitude of employees to clients is professional, they approach each issue comprehensively, offering a wide range of services.

Adam, Poland

We have been cooperating with Konmex for several years. We are satisfied with the services that it offers and performs in the field of biocompatibility tests of medical devices. Konmex employees have a lot of knowledge in this aspect and professionally fulfill their tasks, they also help in the selection of research. The prices of services offered by the company are also attractive

Miłosz, Poland

The knowledge and experience of Konmex proved irreplaceable during the planning and implementation of cytotoxicity tests. Certification tests were carried out on time, maintaining an appropriate price-quality relationship. I can recommend Konmex with full responsibility.

Przemysław, Poland

Thank you Konmex Lab for always professional advice and flexible services. I was very impressed of your modern and advance testing facility in Warsaw. I can highly recommend this team as they fully met our expectations and offered fair pricing. Also fast response time is something worth to mention as its quite important factor nowadays. Once again, thank you for the entire support!,

Agnes, Denmark

Very helpful and responsive throughout the process of Bio-Compatibility testing. I greatly appreciate the communication and quality of the reports. Overall I am very happy with the service and I highly recommend this lab

Muhammad Z., Germany

I recommend cooperation with the Konmex Laboratory to all those who value honesty, reliability and need advice from real specialists in the industry. Mr. Damian honestly chose the number of samples needed for my research, not guided by the desire to profit, but knowledge of the requirements of specialized standards – the result is a solid assessment of the case at a fair price. In addition, the punctuality of the services provided and the legibility of the prepared reports deserves praise. I recommend in all conscience.

Mateusz, Poland

The company Konmex showed a very professional approach in contact with the customer. During CE work Mr Damian was unbelievably helpful in sharing his endless knowledge. We recommend Konmex lab with a calm conscience to everyone who cares about reliable and smooth access to all kind of complex research.

Peter, Czech Republic

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