Professional Team for Medical Device Testing Services
Biocompatibility Test / Performance Test / In Vivo Degradation Test
Master Laboratory Co., Ltd. is a specialized preclinical testing laboratory focused on the unique and rigorous verification needs of advanced medical devices, including complex implants and a broad range of other high-performance devices. We work with clients worldwide to navigate complex regulatory pathways and help them develop clear, successful strategies for market entry.
Core Expertise & Specialized Facilities
We provide comprehensive testing and regulatory intelligence, backed by specialized infrastructure and a team of expert professionals:
-
Elite Scientific Team: Our experts specializes in critical disciplines essential for advanced medical devices, including Toxicology, in vivo Implantation, and Performance Testing.
-
SPF-Grade Laboratory: We operate a state-of-the-art Specific Pathogen-Free (SPF) laboratory, ensuring the integrity and reliability of all animal testing data, a mandatory requirement for complex, long-term contact, and high-risk devices.
-
Integrated Services: We provide detailed Biocompatibility, Performance, and Efficacy Testing services for medical devices, in compliance with international standards, including ISO/IEC 17025, ISO 10993, FDA, and USP.
Industry-Leading Regulatory Expertise and Experience
- U.S. FDA 510(k): extensive experience in providing support for the U.S. FDA 510(k) clearance process for medical devices.
-
Diverse Clearance History: Our Biocompatibility and Performance Test Reports have assisted clients in preparing documentation for 510(k) submissions, supporting compliance with clearance requirements across a wide range of product categories:
LPL: lenses, soft contact, daily wear
- Pioneering Approval Rate: From March to July 2010, our biocompatibility reports supported the 510(k) clearances for five Class II medical devices (K092980 – K092984), achieving an industry-leading approval rate.
-
Global Recognition: Our comprehensive testing and regulatory support services have assisted numerous clients in submitting the required application documents to regulatory authorities in various markets, including Taiwan, the United States, the European Union, and other Asian markets, to help their medical devices meet applicable regulatory requirements for market authorization.
-
Strategic Planning: We provide comprehensive testing, strategic planning, and essential regulatory documentation to facilitate successful global market entry.
Global Quality Assurance
The foundation of our expertise is built on rigorous quality systems that uphold data integrity and support international recognition:
| Certification | Accrediting/Regulatory Body | Global Significance |
|---|---|---|
| OECD GLP Compliance Certificate | Taiwan Accreditation Foundation (TAF) | Facilitates global mutual recognition of non-clinical safety data. |
| GLP Compliance Certificate | Taiwan Food and Drug Administration (TFDA) | Demonstrates compliance with Taiwan's regulatory standards for Good Laboratory Practice (GLP) |
| ISO/IEC 17025:2017 Certificate | Taiwan Accreditation Foundation (TAF) | Indicates the laboratory's technical competence, accuracy, and data traceability in accordance with the relevant standards. |
Trusted by Industry Leaders
Ready to accelerate your product’s global journey? Contact us today to learn how our precilinical testing services can support your regulatory needs and drive successful market entry.