Timian combines extensive knowledge and experience on different areas:
- Medical Devices, Cosmetics and FemCare & Hygienic Products
- Technical file, Safety assessment preparation, Documentation,…
- R&D Activities
- Support with project documentation, management of the projects,…
- Regulatory Affairs Activities
- Regulatory issues, 510(k) premarket approval, Medical Device Directive, New MDR…
- Quality Assurance Activities
- ISO 9001, ISO 27001, ISO 13485, 21 CFR Quality System Regulation compliance
- Quality Control Activities
- Support with Sampling plans & Control plans
- Microbiological Laboratory Analysis
- Microbiological quality, Antimicrobial action (analysis according to ISO 20743, ATTC 100,…)
- Sterilization
- Support with sterilization activities (validation, establishment of routine control,…)
- Consulting and Education
- Information Security Management System
- ISO 27001, ISO 22301, TISAX