We provide support in defining the proper preclinical pathway
We support our clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features.
Thanks to our strategic partnership with 1LAB, a preclinical laboratory specialized in in vitro testing, we can also design ad hoc experimental protocols and testing for topical, bioabsorbable and cardiovascular medical devices, providing important information on the safety and performance of the products for compliance with R&D and regulatory requirements.
1LAB specializes in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin and mucosa.
We provide support in defining the proper preclinical pathway
We support our clients in defining the proper preclinical pathway to assess medical devices’ safety and performance features.
Thanks to our strategic partnership with 1LAB, a preclinical laboratory specialized in in vitro testing, we can also design ad hoc experimental protocols and testing for topical, bioabsorbable and cardiovascular medical devices, providing important information on the safety and performance of the products for compliance with R&D and regulatory requirements.
1LAB specializes in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin and mucosa.
Do you have a medical device composed of substances or combination of substances?
When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21 and the requirement for new verification tests on medical devices composed of substances or combination of substances. If such devices are introduced in the human body, and are absorbed by or locally dispersed in it, these should be evaluated for absorption, distribution, metabolism and excretion (ADME), as required by the applicable conformity assessment procedure under MDR.
We can help you establish the need for such verification studies to be performed according to Directive 2001/83/EC.
Through our partnership with 1LAB, we can also perform screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.), in order to investigate potential for local and systemic absorption, helping you saving time and budget.
Do you have a medical device composed of substances or combination of substances?
When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21 and the requirement for new verification tests on medical devices composed of substances or combination of substances. If such devices are introduced in the human body, and are absorbed by or locally dispersed in it, these should be evaluated for absorption, distribution, metabolism and excretion (ADME), as required by the applicable conformity assessment procedure under MDR.
We can help you establish the need for such verification studies to be performed according to Directive 2001/83/EC.
Through our partnership with 1LAB, we can also perform screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.), in order to investigate potential for local and systemic absorption, helping you saving time and budget.