Leverage our expertise to define your preclinical strategy
As a trusted leader in preclinical research, we offer expert guidance to help you define and formulate a robust preclinical strategy. Our comprehensive range of services helps you gather the relevant data and evidence needed to support the safety and effectiveness of your products.
With over a decade dedicated to Academic Research and Innovation, coupled with deep Regulatory expertise, our Preclinical Science & Regulatory Department is your dedicated partner for preclinical services. We help you design ad hoc scientific assessment reports, experimental protocols and testing tailored to assess the safety, efficacy and performance of medical devices, cosmetics, and food supplements. Our personalized support guarantees that your products not only meet but exceed the crucial benchmarks for safety and performance, ensuring compliance with stringent R&D and regulatory requirements.
1Med’s Preclinical Science & Regulatory Department has its own cutting-edge laboratory, specialized in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human tissues.
Leverage our expertise to define your preclinical strategy
As a trusted leader in preclinical research, we offer expert guidance to help you define and formulate a robust preclinical strategy. Our comprehensive range of services helps you gather the relevant data and evidence needed to support the safety and effectiveness of your products.
With over a decade dedicated to Academic Research and Innovation, coupled with deep Regulatory expertise, our Preclinical Science & Regulatory Department is your dedicated partner for preclinical services. We help you design ad hoc scientific assessment reports, experimental protocols and testing tailored to assess the safety, efficacy and performance of medical devices, cosmetics, and food supplements. Our personalized support guarantees that your products not only meet but exceed the crucial benchmarks for safety and performance, ensuring compliance with stringent R&D and regulatory requirements.
1Med’s Preclinical Science & Regulatory Department has its own cutting-edge laboratory, specialized in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human tissues.
Do you have a medical device composed of substances or combination of substances?
Streamline your path to MDR compliance effortlessly with 1Med. When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21. This mandates new verification tests on medical devices made up of substances or combinations 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), aligning with the applicable conformity assessment procedure under the new MDR.
At 1Med, we excel in guiding you through the intricacies of compliance. Our specialized services are designed to help you determine the need for critical verification studies, ensuring alignment with Directive 2001/83/EC.
Through our cutting-edge Preclinical Science & Regulatory Lab, we also offer screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.). These tests explore the potential for both local and systemic absorption, providing valuable insights, helping you save time and budget, and accelerating your journey to success.
Let us customise tests specifically for your needs, revealing vital information about your product’s behaviour. Your journey to compliance starts here.
Do you have a medical device composed of substances or combination of substances?
Streamline your path to MDR compliance effortlessly with 1Med. When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21. This mandates new verification tests on medical devices made up of substances or combinations 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), aligning with the applicable conformity assessment procedure under the new MDR.
At 1Med, we excel in guiding you through the intricacies of compliance. Our specialized services are designed to help you determine the need for critical verification studies, ensuring alignment with Directive 2001/83/EC.
Through our cutting-edge Preclinical Science & Regulatory Lab, we also offer screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.). These tests explore the potential for both local and systemic absorption, providing valuable insights, helping you save time and budget, and accelerating your journey to success.
Let us customise tests specifically for your needs, revealing vital information about your product’s behaviour. Your journey to compliance starts here.