MedTech Consultation

by | Jan 19, 2017 | 0 comments

EAP MedTech Consulting Sdn Bhd: Building Medical Devices Toward 510K and CE Marks

As a company, EAP MedTech Consulting Sdn Bhd (EAP), a Malaysian based company, provides training and consultation services that help clients incorporate regulatory-compliant practices in every stage of development for medical devices product development and manufacturing.

Not surprisingly, this consulting firm also specializes in product design and development, working actively towards the improvement and international-standard quality of these phases of medical device production. In providing contract medical device manufacturing for clients in the Asia/Pacific region, EAP has used its years of experience in the medical industry to produce medical device components and complete medical devices certified by 510k and CE mark approvals where applicable in order to secure distribution to worldwide markets.

Overseeing different phases of the product development of medical devices, EAP consultants are equipped with knowledge and experience in regulatory affairs and quality assurance, applying risk management and usability engineering to medical devices in line with ISO 14971 and IEC 62366 respectively.

In short, EAP assures that medical devices meet the standards of relevant medical device directives and other regulatory guidelines that must be met in order for distribution and marketing in various markets.

For example, to distribute any type of device, including medical devices, in any European market, manufacturers and sellers are legally required to attain a CE mark. For this reason, EAP acts as a quality assurance consultant that actively incorporates regulatory requirements and approved operations practices throughout product design and development stages, providing conformity assessment services for a wide range of clients in Asia/Pacific.

With this diverse team, many medical device consultation firms like EAP seek to advise clients on the timeline, requirements, testing and rigorous process validation activities that are necessary in the quest to achieve the CE Mark and make available some of the most innovative and top quality medical devices in lucrative global markets.


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