For non-EU based manufacturers and importers of most CE/GS marked products as per (EU)2019/1020 on market surveillance and compliance of products
EU Authorised Representative as per (EU)2017/745(MDR) and (EU) 2017/746 (IVDR), technical documentation review & verification, Class I medical device and IVD registration, Certificates of Free Sales
Cosmetic Product Information Files(PIF), safety assessment, product registration via the Cosmetic Product Notification Portal(CPNP), Cosmetic Product Safety Report creation, cosmetics ingredients & labeling review
For personal protective equipment as per PPE Regulation (EU) 2016/425: draft compliant DoC , establish technical file, assist in notified body test & certification
For producers and distributors of electronical and electronic equipments in the EU as per 2012/19/EU: registration, regular declaration of material, information to end-users and marking requirements, information made available to recyclers, organization, financing & outcomes reporting of take-back and recycling, report outcomes
For manufacturers and distributors of products with packaging and packaging waste as per 94/62/EC or VerpackG(Germany) or France: assessment of sales model and producer status, local registration, impliment collection and recycling systems, support in declaration to EN 13428, Packaging: Requirements specific to manufacturing and composition, assist in packaging toxing testing
We are a multidisciplinary team with technical supervisors, compliance consultants, branch experts, international trade and marketing specialists. We work together to create, implement and optimize strategic and operational guidance and practices to help non-EU based manufacturers and traders to comply with any relevant EU rules before their products can be traded freely in the EU.
