OneLink: OneSolution (OLOS) is a dynamic, quality-driven network of international experts from independent companies who offer advanced regulatory consultation, directive assistance, language compliance solutions and new market penetration strategies.
MTC – Australia can provide a complete service for manufacturers, importers and exporters of medical devices, from concept to market.
Dr. Derrick Beech created and implemented medical device regulation in Australia as Director, Therapeutic Devices Branch, Therapeutic Goods Administration from 1985-96. He provides a full service for the medical device industry including quality systems, reimbursement, regulatory compliance, business development, clinical trials, CE Marking for the EU, FDA approval, international and local market access, strategic advice in dealing with the TGA and overseas regulatory agencies. This innovative company has joined forces with OneLink: OneSolution, increasing the range of possibility for OLOS clients.
OLOS currently offers mutual clients regulatory expertise covering the global market domestic regulations in: EU (CE), USA (FDA), China (SFDA), Korea (KFDA), Brazil (AMVISA), Australia (TGA), Israel, India, Malaysia, Philippines and Vietnam. In addition, OLOS also provides the following services: continuous monitoring of regulatory compliance, Technical Construction File review, QMS implementation, product safety consultancy, product testing and certification services, call center services and Global Market Solutions business development.
OLOS’ vision is:
To have a committed network of independent associates who share the same high standards, qualities, and values.
To create an environment of reciprocity and equality among the network with its mutual clients
To maintain and perfect its set of solutions to answer the ever growing demand of global regulations
To serve new industries in which the network’s services are required
To further develop OLOS into a powerful and prominent network
Obelis will be featuring its OLOS network at Medica 2008 (www.obelis.net).