WE SPECIALIZE IN
Our mission is to continuously strive to become a trusted and respected partner by providing the best services to our clients, which will ultimately improve the lives of the patients they serve.
Local Representation
We act as your In Country Representative in Asia, helping you successfully navigate Asian medical markets.
Regulatory Strategy
We implement a customized medical device regulatory strategy to match your requirements.
Quality Management Systems
As experts in GDPMD, ISO13485, and the US FDA Quality System, we can support you in meeting your QMS requirements.
Business Development Services
We offer a broad range of business services, including market research, manufacturer audits, and distributor searches.
Clinical Evaluation
We ensure that clinical research meets international standards and adheres to local ethical committee requirements.
Medical Device Servicing
We provide a comprehensive service and repair program to support manufacturers and local distributors in managing the installation and ongoing maintenance requirements of their customers.
Training & Support
We provide “real world training” to support you in the development of medical devices that meet international quality standards, EU medical device directives, and CE marking requirements.
Our Commitment To You
Striving towards excellence to become your trusted and respected partner in Southeast Asia
TRANSPARENCY
Total openness in business and HR policies
INTEGRITY
Truth, honesty and sincerity
EXCELLENCE
Exceed our clients’ expectations, always!
ACCOUNTABILITY
Demonstrate the ownership necessary to achieve our common goals
ETHICS
Comply with local and international regulations
We Value Our Clients Trust In Our Services
Testimonials
Read our customers’ testimonials all over the world.
Andaman Medical is providing excellent expertise in different Regulatory, Quality & Clinical disciplines. The appointed consultant understood quickly our business and technical needs. We are now guided from concepts through the operational implementation with our different local markets organizations. Andaman is actually our exclusive partner for all ASEAN countries and more.
Since about 2 years, Mourad Kholti works for DEKRA as lead auditor for the EU Medical Device Directive and ISO13485. Mourad performs according to the high standards of DEKRA. The combination of his strong background in Medical Devices manufacturing, regulatory and quality management, his keen observations and communication skills are well appreciated by both DEKRA and DEKRA’s customers.
We appreciate working with Andaman Medical. We are very satisfied with your reactivity and we find you very helpful. Andaman Medical has a high level of competence and the consultants are attentive to our needs. We strongly recommend Andaman Medical and if we expand our business, we will use your services again in the Asia-Pacific region
Good regulatory consultant to work with. The staff are knowledgable and they handle all enquiries promptly and efficiently. The client requirements/queries are rightly analyzed, and consultants provide valuable feedback. Keep up the good work!
We are satisfied with the service we receive from Andaman Medical, their professional regulatory advice, and the monthly follow-up support. The support from Andaman Medical is always quick and clear and we are tremendously grateful for the service
We have been cooperating with Andaman Medical for more than a year. They are very professional, extremely organized, and prompt in responding to all our questions and queries. We appreciate the expertise of the staff and their customer-oriented attitude, and we are grateful for their regulatory support when entering new markets.
Since appointing Andaman Medical as our partner, their consultants have been great in assisting us in understanding the MDA’s regulations. Their service have always been prompt and professional. It demonstrates the competence of Andaman Medical. We look forward to a great long-lasting relationship with Andaman Medical.
Need Answers? Contact Our Team
Andaman Medical is always ready to help new clients navigate new markets in ASEAN. Our services extend to Medical Device Regulatory, Clinical Evaluations, Quality Management Systems, Authorized representation, Business Support and Training. Please contact us for a FREE consultation where can discuss the best options for your company.