About Swiss-Graft®
Pioneering bone regeneration technology with Swiss precision and medical excellence
Our Mission
Swiss-Graft® is dedicated to advancing the field of regenerative medicine through innovative, scientifically-validated bone graft materials. We combine Swiss precision engineering with cutting-edge biomaterial science to provide healthcare professionals worldwide with reliable, effective solutions for dental implants, periodontal regeneration, and oral & maxillofacial surgery.
Our commitment is unwavering: to enhance patient outcomes through superior biocompatibility, predictable osseointegration, and clinically-proven bone regeneration materials that represent the pinnacle of medical excellence.
Manufacturing Excellence
Our state-of-the-art manufacturing facility in Switzerland represents the convergence of traditional Swiss craftsmanship and modern biotechnology. Every product is manufactured under strict quality control protocols, adhering to ISO 13485 medical device standards and CE regulatory requirements.
Our production process combines automated precision equipment with expert manual oversight, ensuring that every unit meets our exacting standards for biocompatibility, sterility, and clinical efficacy. We invest continuously in research facilities and equipment to maintain our position as a leader in regenerative medicine innovation.
Our Core Values
🔬 Scientific Integrity
Every product is backed by rigorous research, peer-reviewed clinical studies, and continuous scientific validation. We prioritize evidence-based advancement in regenerative medicine.
🏥 Patient-Centric Design
We design our materials with patient outcomes as the primary objective. Superior biocompatibility and predictable healing lead to better clinical results and enhanced quality of life.
⚙️ Swiss Precision
Quality is not negotiable. We maintain the Swiss reputation for precision, reliability, and attention to detail in every aspect of manufacturing and distribution.
🌍 Global Responsibility
We serve healthcare professionals worldwide while maintaining ethical sourcing practices and sustainable manufacturing processes that respect both patients and the environment.
🔒 Safety First
Comprehensive donor screening, multi-stage sterilization, and rigorous biocompatibility testing ensure that every Swiss-Graft® product meets the highest safety standards in medical device manufacturing.
🚀 Continuous Innovation
We invest in research and development to advance regenerative medicine. Our commitment to innovation drives the creation of next-generation bone graft materials.
Swiss Heritage & Expertise
Founded in Switzerland, the birthplace of precision manufacturing and medical innovation, Swiss-Graft® embodies the values that have made Swiss medical devices synonymous with quality worldwide. Our heritage is built on decades of experience in biomaterial science, regulatory compliance, and clinical research.
Switzerland's unique position in global healthcare—combining regulatory excellence, scientific leadership, and ethical manufacturing practices—shapes every aspect of our operations. We don't simply manufacture products; we craft solutions that advance human health.
Regulatory Compliance & Certifications
Our Journey
Swiss-Graft® Establishment
Swiss-Graft® was founded by a team of distinguished biomaterial scientists and clinical specialists with a unified vision to revolutionize bone regeneration through cutting-edge material science and precision manufacturing.
Manufacturing Facility Launch
Inaugurated our state-of-the-art manufacturing facility in Switzerland, establishing ISO 13485 certified production capabilities with advanced quality control systems and automated precision equipment.
First Product Line Release
Successfully launched Swiss-Graft® Xenograft Bone Graft with clinical validation data demonstrating superior osseointegration rates (85-95%) in dental implant and oral surgical applications.
CE Certification Achievement
Achieved CE marking (Class II Medical Device) and FDA registration, enabling distribution across European and North American markets with full regulatory compliance.
Advanced Allograft Introduction
Introduced Swiss-Graft® Allograft Bone Graft with proprietary demineralization technology, providing superior osteoinductive properties and establishing new clinical outcome benchmarks in regenerative medicine.
Global Expansion & Innovation
Expanding to serve healthcare professionals across multiple continents, investing in research for next-generation products, and advancing regenerative medicine through clinical innovation and medical excellence.
Advanced Manufacturing & Quality Standards
At the heart of Swiss-Graft® excellence lies our commitment to ISO Class 6 cleanroom manufacturing standards. Our facilities maintain particulate contamination levels of ≤3,520 particles/m³ (≥0.5 µm), exceeding regulatory requirements for medical device production and ensuring sterile, contamination-free manufacturing of all bone graft materials.
Cleanroom Technology & Biocontainment
Our ISO Class 6 cleanroom environment represents state-of-the-art pharmaceutical manufacturing technology. Environmental parameters are continuously monitored and maintained:
- Temperature Control: ±2°C precision (20-24°C optimal range)
- Humidity Regulation: 45-55% RH with continuous monitoring
- Positive Pressure: 12.5 Pa above ambient to prevent external contamination
- HEPA Filtration: 99.97% filtration at 0.3 µm (10,000:1 efficiency ratio)
- Air Changes: Minimum 20 air changes per hour (ACH) for optimal sterility
- Particulate Monitoring: Real-time laser particle counters with alert systems
Scientific Processing & Quality Control
Each batch of Swiss-Graft® bone graft material undergoes rigorous scientific analysis and quality verification at multiple production stages:
Comprehensive Testing Protocol
- Histological Analysis: Light and scanning electron microscopy (SEM) to verify microarchitecture, porosity distribution (macropores 200-500 µm, micropores <10 µm), and collagen preservation
- Biocompatibility Testing: ISO 10993 cytotoxicity assays, sensitization tests, and genotoxicity studies on L-929 mouse fibroblasts and primary human osteoblasts
- Sterilization Validation: Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11135 (ethylene oxide sterilization); biological indicator validation with Geobacillus stearothermophilus spores
- Endotoxin Quantification: Limulus Amebocyte Lysate (LAL) assay per USP <85> with limits ≤5 EU/device (Medical Device Reporting compliance)
- Osteoinductivity Assessment: BMP quantification via ELISA (Enzyme-Linked Immunosorbent Assay); growth factor stability testing (VEGF, FGF, IGF-I, BMPs)
- Mechanical Properties: Compressive strength testing (12-22 MPa range verification), tensile analysis, and elasticity modulus confirmation
- Particle Size Distribution: Laser diffraction analysis and sieve analysis per ISO 13823 confirming 250-1000 µm particle size consistency
- Resorption Kinetics: In vitro degradation studies simulating physiological conditions; osteoclast-mediated resorption rate validation (8-14 months linear degradation)
At Swiss-Graft®, excellence is not a destination—it's a continuous journey. We are committed to:
- Scientific Leadership: Advancing the field of regenerative medicine through peer-reviewed research and clinical innovation
- Uncompromising Quality: Manufacturing products that consistently exceed international medical device standards
- Ethical Operations: Maintaining the highest ethical standards in sourcing, manufacturing, and distribution
- Healthcare Professional Support: Providing comprehensive training, technical support, and clinical resources to our partners
- Patient Outcomes: Ensuring that every Swiss-Graft® product enhances patient care and clinical results