About MedServ
In the field of medical devices, a trustworthy, responsible, and professional partner
Our mission is to provide you with the expertise and testing solutions you need to verify designs, meet regulatory standards, ensure reliable performance, and bring your products to market on time and on within budget.
MedServ was established in 2016, with a service scope covering international medical device research and development, manufacturing, testing, and regulatory certification, offering integrated one-stop solutions for the entire product lifecycle. We assist both domestic and international medical industries in manufacturing (ISO 13485) and applying for market permits. We engage in mutual exchanges with medical centers, incorporated foundations, academic institutions, and other units, providing professional services in physical properties, packaging materials, sterilization, biocompatibility, chemical properties, electromagnetic compatibility, safety regulations, and environmental reliability, pioneering a new era of intelligent medical manufacturing. In addition, we continue to promote technical guidance for medical manufacturing producing eco-friendly medical materials, and collaborating with medical institutions to implement low-carbon medical care. We formulate smart decarbonization strategies to achieve the goal of net-zero emissions for the sustainable development in the upstream and downstream of the medical industry.
Quality and delivery goals
We are proud of the details and quality requirements in serving our customers and our expertise in the field of medical devices. We strive to build a good relationships with each customer, enabling them to better understand how we assist from product conception to market launch and achieve their goals.
MedLab is Taiwan’s first comprehensive third-party impartial testing laboratory for medical devices. The laboratory capacity covers the mechanical and biological fields, and it is a professional laboratory that complies with the ISO/IEC 17025 international standard certification. Testing reports are aligned with the International Laboratory Accreditation Cooperation(ILAC) for international recognition.
We aim to assist our customers in realizing excellent medical device products. In order to achieve the goal, we provide established or customized services to assist you address the challenges encountered in R&D, certification, and testing comprehensively. Our mission is to fully resolve your issues and meet the requirements for launching your product into the market.
Key Milestones
2016
MedServ was established
Medical device market launch services
2017
Medical device testing laboratory was established
The first third-party impartial inspection enterprise to provide medical implant mechanical testing services in Taiwan.
2018
Increase service scope
(trauma, spine, dental, joints, dressings, and other medical devices)
1. R&D services
(Drawing, numerical analysis, and 3D printing prototyping)
2. Testing services
(ISO 17025 and TAF)
3.Manufacturing facility guidance services
(QMS, ISO 13485, and risk management, etc.)
4. Regulatory consultation
(FDA, TFDA, NMPA, and other international regulatory consultations)
2019
TAF testing certification conversion
1. Comply with ILAC international requirements
2. Applicable countries: China, United States, United Kingdom, Germany, Japan and many other countries
2020
Guidance and certification for establishing factories and marketing of epidemic prevention medical devices.
1. Medical masks
2. Medical protective clothing
3. Covid-19 rapid Antigen Test
4. Other protective medical devices
2021
Enhancing service capacity
1. Packaging material testing for medical devices
2. Residual cleaning test
3. Sterilization validation test
2022
Enhancing service capacity
1. Consulting for Good Distribution Practice(GDP) in medical
devices sales.
2. Cleanroom hardware planning, design and construction
3. Temperature mapping service
4. Plate count test service
5. Dust fall test service
2023
Microbiology laboratory was established
1. Sterilization validation service
2. Sterility testing services
3. Cytotoxicity test
2024
Expected to establish the headquarters in Machohou,
Chiayi in Q4.
About our the team
MedServ was founded by Dr. Lee Chia-Ching and consists of a group of experts passionate about medical devices. The team includes mechanical PhDs, environmental engineering PhDs, biomedical elites, academic research units, physician consultants, and senior regulatory consultants. With extensive experience in the fields of orthopedics, spinal surgery, and dentistry, the team has observed the global trend of aging population, leading to an increasing demand for medical devices. MedServ chooses to assist medical device manufacturers or distributors in launching their products to market.
Central Office：+886-2-2995-6899
FAX：+886-2-2278-2859
Phone：+886-921290329
E-mail : info@medserv-biotech.com
Taiwan Company
1, No. 145, Zhongshan Rd, Xinying District, Tainan City, 730
Taiwan Officea
a, No. 172, Section 2, Guangfu Rd, Sanchong District, New Taipei City, 241
Malaysia Office
Lot 4-1B, Lukas Ark Digital Mall, Lengkok Nipah, Taman Lip Sin 11900 Bayan Lepas, Penang Malaysia