Preclinical Services
Leverage our expertise to define your preclinical strategy
1MED specializes in preclinical research, offering expert guidance to formulate robust strategies. With over a decade in Academic Research, Innovation, and Regulatory expertise, our Preclinical Science & Regulatory Department provides tailored testing for medical devices, cosmetics, and food supplements. We ensure products meet stringent safety and performance benchmarks through advanced testing in biomaterial scaffolding and tissue engineering technologies.
Trust 1MED for comprehensive preclinical solutions that exceed regulatory standards.
Do you have a medical device composed of substances or combination of substances?
Streamline your path to MDR compliance effortlessly with 1MED. We specialize in navigating the complexities of the new Medical Device Regulation (MDR), including the introduction of classification Rule 21.
This mandates verification tests for medical devices containing substances absorbed by the human body, ensuring alignment with Directive 2001/83/EC. Our advanced Preclinical Science & Regulatory Lab offers in vitro permeation tests on various substrates, such as skin and mucosa, to assess absorption potential. Let us tailor tests to your specific needs, providing crucial insights and accelerating your compliance journey.
This mandates verification tests for medical devices containing substances absorbed by the human body, ensuring alignment with Directive 2001/83/EC. Our advanced Preclinical Science & Regulatory Lab offers in vitro permeation tests on various substrates, such as skin and mucosa, to assess absorption potential. Let us tailor tests to your specific needs, providing crucial insights and accelerating your compliance journey.
Testing:
- Cytotoxicity (ISO 10993 or custom)
- Irritation test (ISO 10993 or custom)
- Corrosion test (OECD)
- Sensitisation (ISO 10993 or custom)
- Hemocompatibility
- Chemical characterisation
- Absorption test in accordance with OECD 428
- Mechanism of action investigation
- Anti pollution efficacy
- Antioxidant properties
- Anti-aging potential
- Skin brightening and whitening
- Anti acne evaluation
- Soothing properties
- Dry eye efficacy
- Oral products efficacy
- Antacid capacity
- Barrier and film forming properties
- Recovery and regeneration efficacy
- Effect on native microbiome
- Rheological characterisation
- Mucoadhesive properties
- Pro proliferative properties
- Effect on tissue permeability and integrity
Regulatory and scientific support:
- Biological Evaluation Plan and Report
- Assessment Report
- Chemical Characterisation Plan
- Support for Resolving Non-Conformities
- Support for Medical Device Risk Analysis
- Toxicological Risk Assessment
- Support in the Design of Experiments
- Cosmetic Product Information File (PIF)
- Cosmetic Product Claim Substantation
- Courses and Workshops