For products and devices to be certified for use in the medical field, it is mandatory for medical devices to be CE marked. A conformity mark under the European Economic Area (EEA), CE marking certifies that products sold within a market meet EU consumer safety, health, and environmental standards and requirements.
ACE Bureau is dedicated to providing clients with our expertise in this domain, assisting clients through the CE marking procedures under the Medical Devices Directive. We guide our clients through the various stages of the marking procedure, namely classification of the medical devices, risk assessment tests for the devices, ensure that essential requirements are met in accordance with the Annex I of 93/42/EEC such as testing against EN 60601-1 for electrical safety, as well as providing conformity assessments for your medical devices and products.
ACE Bureau’s appointed laboratories, which are notify bodies under the EU's Medical Devices Directive (93/42/EEC) are able to provide services under all Annexes for a multitude of categories. In addition, we provide assistance to our clients in their technical filings and documentation to demonstrate conformity to the directive which involves elements of Design History files and Device Master Records.
Our auditors and inspectors are situated worldwide to service our global network of clients. We offer consultancy services to help your company comply with the ISO 13485. We provide assistance with obtaining approval from various agencies such as FDA 510(K) in the United States of America and State Food and Drug Administration (SFDA) in China among others, to be granted permission to market your medical devices and products into zones such as Australia, Canada, Japan, Korea, Thailand, Philippines, Indonesia, Singapore, Malaysia, Hong Kong, Saudi Arabia, India, South Africa and more.