Blue Broccoli GmbH

Blue Broccoli is your partner for Medical Devices Regulatory & Quality Management as well was as Sourcing and Manufacturing in Asia!

The two Blue Broccoli founders have 25 years of collected experience in Medical Devices Regulatory and Quality Management Systems. Completed MDD Annex II certifications for Class I, IIa, and IIb medical devices from scratch (including building up Quality Management System, Technical Documentation, Validations). Built a global cooperation’s QMS with de-centralized R&D and manufacturing setup. Submit and cleared tens of FDA 510k approvals. Supervised Class I, II, and III medical devices approvals in CFDA and TFDA.

We understand that modern organizations work more and more de-centralized and that the management tools need to be adopt such structures. Its absolutely essential to use latest collaboration tools to reduce manual workload, reduce time to market, and to be able to comply to the wide range of regulations.

Specially in the field of medical devices the amount of technical data that needs to be exchanged between buyer and supplier is significant. This may contain conditional trade secrets. Based in Vaduz, the capital of Liechtenstein in the heart of Europe where integrity is a key value, we treat our customers data with highest level of confidentiality.

Blue Broccoli, working in Asia since 2003, has a wide network of manufacturers in Mainland China and Taiwan for the development and manufacturing of Electronic Medical Devices as well as Lifestyle Products.

Company’s Keywords:

medical devicve, mdr, fda, product development, asia sourcing, asia market access, quality management system, software, software medical device, eudamed, authorised representative