Jordi Labs

09/26/2022

Healthcare-centred professional services firm RQM+ has acquired Jordi Labs for an undisclosed fee.

09/07/2022

We have been acquired by +! We'll add to their growing expertise with laboratory services to support market access throughout the entire product lifecycle for medical devices and diagnostics. We’re really excited to join the RQM+ team!

Read the press release here.

RQM+, the leading MedTech service provider today announced the acquisition of Jordi Labs. Read on.

08/31/2022

In June 2022, Kurt Thaxton and Jan Garbe-Immel of GERSTEL launched their brand new edutainment podcast series Labworks True Podcast in which they delve into the work of analytical chemistry. We were fortunate enough to have Mark, our President, be invited onto episode one to discuss what Jordi Labs does, some of the problems we’ve solved for clients as well as talk about some funny quirks such as: what made printed paper smell like cat urine?

Mark Jordi introduces himself and Jordi Labs in LabWorks True Podcast as they discuss analytical chemistry, K cups and the smell of roses. Read more.

08/05/2022

The medical device development process is certainly not as simple as bringing an idea from the thought process through to production. There are many different hurdles to overcome, potential hazards to consider and devices must be approved before they can be manufactured. Creating new products is no easy feat, and this blog post aims to dig deeper into the product development process of medical devices.

The planning stages of developing a medical device will include market research, gathering a development team and identifying your target audience. Read more.

08/02/2022

The potential health risks from a medical device are numerous. Toxicological risk is determined by exposure time, concentration and the severity of the chemical species involved. The FDA tries to incorporate these risks into the proposed chemical characterization tests as part of ISO 10993 by insisting on different biological endpoint tests depending on where and how long a medical device will be used.

Read more!

The Food and Drug Administration (FDA) ISO 10993 guidance is one of the most important for the chemical characterization testing of medical devices.

08/02/2022

Equivalence, in the context of medical and pharmaceutical devices, is the process of being able to show that two devices are equivalent to each other in terms of safety and clinical ex*****on. By this definition, equivalence is not just being 'similar' to something—it's much more.

Learn how chemical characterization testing factors into equivalency with our latest blog post.

The chemical characterization of materials is important to assess how safe a product is, based on the materials it is composed of. Read on to find out more.

06/22/2022

The biological endpoints which are required to be evaluated under biocompatibility evaluations depend on the nature and duration of exposure. These endpoints can include cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemocompatibility, implantation, genotoxicity, carcinogenicity, and reproductive and development toxicity. These endpoints may be addressed through existing data, through justification regarding their relevance to the clinical use case, or through new testing of the device.

Biocompatibility Evaluations are designed to assess whether a product is safe for its intended use depending on its composition.

06/10/2022

At Jordi Labs, we have extensive experience providing expert regulatory consultations and toxicological risk assessments. Our aim is to provide end-to-end support for valued customers, from the earliest stages of product development through to regulatory submissions support.

Jordi Labs provides expert biological evaluation consulting services for product development of medical devices and pharmaceutical packaging systems.

06/06/2022

The chemical characterization testing that needs to be performed for medical devices needs to include several scenarios. This might consist of extractable testing under exaggerated use conditions or leachables testing in the types of environments the device will be exposed to in the body. It may also include chemical characterization testing for worst-case chemical release scenarios.

The Food and Drug Administration (FDA) ISO 10993 guidance is one of the most important for the chemical characterization testing of medical devices.

06/03/2022

The so-called “Big Three” biological assessments involve tests for cytotoxicity, skin sensitization, and irritation testing. But there is no rinse-and-repeat approach to biological evaluations, and proposed actions will vary depending on the nature of the product, the novelty of materials used in its fabrication, and the requirements of relevant legislation.

At Jordi Labs, we provide pre-clinical biological evaluation consulting services to help with toxicological risk assessments. Learn more.

05/31/2022

A toxicological risk assessment should describe all aspects of toxicological risk, including safe exposure limits in concentration and time. Performing a complete toxicological risk assessment is critical in approving any new medical device and can be time-consuming and costly if not handled with expert care.

A toxicological risk assessment should describe all aspects of toxicological risk, including safe exposure limits in terms of concentration and time.

05/27/2022

Jordi Labs provides a wide range of pre-clinical testing services designed to help our partners realize the potential of their own products. We can help with product design, material selection, chemical testing, protocol design, and more, with an ever-growing team of Ph.D. chemists ready and available to provide innovative solutions to your unique problems. If you are interested in our biological evaluation services, why not contact a member of the Jordi team today?

Jordi Labs provides expert biological evaluation consulting services for product development of medical devices and pharmaceutical packaging systems.