MEDICAL DEVICES

LABORATORY TESTS

 

Lab4LIFE offers a wide range of microbiological and physic-chemical tests for pharmaceutical and medical device industry:

  • Bioburden test;
  • Sterility test;
  • LAL test;
  • Challenge test according to Ph. Eur.;
  • Microbiological analysis on pharmaceutical according to Ph. Eur.;
  • Evaluation of efficacy for disinfectants;
  • Sterilization and washing process validation;
  • Stability and shelf life evaluation using accelerated aging tests with ICH climate chambers;
  • Clean room validation;
  • EO residuals;
  • Packaging validation;
  • Global and specific migrations;
  • Materials characterization according to ISO 10993-18;
  • Formulations for cutaneous / nasal / buccal use - In vitro permeation test in Franz cell for the evaluation of the functionality of medical devices based on substances, useful for their classification according to REGULATION (EU) 2017/745

 

BIOCOMPATIBILITY TESTS

 

In partnership with a fully compliant to GLP and ISO 17025 test facility we can offer the complete list of biocompatibility tests according to ISO 10993 standards.

  • Cytotoxicity according to ISO 10993-5;
  • In vitro and in vivo skin irritation according to ISO 10993-10;
  • In vivo skin sensitization according to ISO 10993-10;
  • Haemocompatibility tests according to ISO 10993-4;
  • Subcutaneous / muscular / bone implant according to ISO 10993-6;
  • Genotoxicity tests according to ISO 10993-3;
  • Subchronic toxicity according to ISO 10993-11;
  • Materials characterization tests according to ISO 10993-18;

 

 

CONSULTANCY

 

Our team has built up specific competence in the regulatory framework of medical device class I, IIa IIb; III. We can support our customers in resolving issues related to regulatory compliance and assessment of the safety and effectiveness and process.

 

Main consultancy services:

  • Support for the design of the biological risk assessment of medical devices and the planning of the best testing strategy based on the new requirements of ISO 10993-1:2018;
  • Toxicological evaluation of data obtained from chemical characterization tests of components of medical devices;
  • Classification of medical devices based on substances according to the new REGULATION (EU) 2017/745
  • Planning the best testing strategy for the pre-clinical assessment of medical devices for dentistry use according to ISO 7405;
  • Design of Study Protocols according to ISO 10993 series;
  • Design of operating protocols for sterilization process;
  • Design of operating protocols for washing process;
  • Design of Scientific rationale for the biocompatibility assessment of medical devices;
  • Support to clinical evaluation according to MEDDEV 2.7.1 (rev.4) guideline;
  • Evaluation of toxicological data to support product efficacy and safety;

 

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Lab4LIFE is an UNI EN ISO/IEC 17025 accredited laboratory. For complete schedule of accreditation please check our download page
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