Medical Device Consultancy Service – Asia

Andaman Services Norris Capsie 2018-11-05T16:51:38+00:00

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.

"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

"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.

"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"

- Tetsuo Murakami
Japanese Organization for Medical Device Development, Inc.

"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 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

Andaman Services

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