Medical Device Development & Evaluation
Alta Stomatology is an innovative company specializing in the development of dental medical devices. We are dedicated to providing our clients with comprehensive and professional medical device development and evaluation services, helping them succeed in a highly competitive market. Our wide range of services includes medical device development, intervention and implant effectiveness evaluation, biocompatibility evaluation, orthopedic material evaluation, regulation support, and more. By adhering to rigorous scientific methods and high technical standards, we ensure the safety and effectiveness of every medical device in clinical applications. If you have any needs, please feel free to contact us.
Our Services
Medical Device Development
Alta Stomatology specializes in the development of dental medical devices, offering comprehensive professional services to ensure the safety and effectiveness of products. Our development services cover every stage from concept to preclinical, including feasibility studies, design and prototyping, preclinical testing, and regulatory compliance. Our team of experts utilizes the latest technologies and manufacturing processes to ensure the quality and safety of every dental medical device we develop.
Medical Device and Orthopedic Material Evaluation
Good biocompatibility is a prerequisite for the safe and effective clinical application of dental medical devices. Alta Stomatology provides comprehensive biocompatibility evaluation services for dental medical devices to determine the level of risk of potential toxicity and adverse biological reactions due to contact between dental devices and the oral cavity. In addition, we offer comprehensive orthopedic material evaluation services to assess the mechanical properties, corrosion resistance, and biocompatibility of orthopedic materials.
| In Vitro Cytotoxicity Test |
Sensitization Test |
Irritation Test |
| Systemic Toxicity Test |
Genotoxicity Test |
Hemocompatibility Test |
| Implantation Test |
Pyrogenicity Test |
Material Characterization |
| Wear and Fatigue Test |
Biological Response Evaluation |
|
Regulation Support
Alta Stomatology offers comprehensive regulation support services, including:
Understand Regulatory Requirements: We provide detailed guidance on the regulatory requirements in various regions, including the FDA (USA), CE marking (Europe), and other international standards.
Prepare Documentation: Our team assists in preparing all necessary documentation, including technical files, design dossiers, and clinical evaluation reports.
Regulatory Submissions: We manage the submission process, ensuring that your applications are complete, accurate, and submitted on time.
Post-Market Surveillance: After your device is on the market, we help you monitor its performance and comply with ongoing regulatory obligations.
Species
Rats, mice, rabbits, dogs, pigs, monkeys, etc.
Why Choose Alta Stomatology?
Our team of experts at Alta Stomatology is highly experienced in the field of dental medical device development and evaluation. We have the knowledge and skills to ensure that our client's products meet all regulatory and quality standards.
- State-of-the-Art Facilities
Our cutting-edge laboratories and testing facilities are equipped with the latest technology and instrumentation, enabling us to conduct precise and reliable evaluations. This infrastructure supports our ability to perform a wide range of tests and analyses, ensuring that we can meet the diverse needs of our clients.
We offer a comprehensive range of services, including medical device development, intervention and implant effectiveness evaluation, biocompatibility evaluation, and orthopedic material evaluation. Our integrated approach allows us to provide our clients with end-to-end solutions tailored to their specific needs.
At Alta Stomatology, we prioritize quality and compliance in everything we do. We adhere to strict regulatory standards and best practices in medical device development and evaluation to ensure the safety and effectiveness of every device we work on.
For research use only. Not
intended for any clinical use.
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