Home 2019-03-20T11:10:47+08:00

Medical Device Regulatory Experts In Southeast Asia

Singapore

Malaysia

Indonesia

Philippines

Thailand

Vietnam

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 GDPMDISO13485, 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.

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.

Khalid Azzouzi, Nestle Health Science

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

Sylvain Fogola, Olea Medical

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!

Oculus Private Ltd., Oculus Private Ltd.

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.

Mojca Valjavec, Biocartis N.V.

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.

Jonathan Soh, Hitachi Medical

Need Answers? Contact Our Team

Andaman Medical is always ready to help new clients navigate new markets in ASEAN. Please contact us for a FREE consultation where can discuss the best options for your company.