Standards Compliance – where Innovation meets old tech
Does your product change the world? It’s often the case that a new invention doesn’t fit the technical standards which apply to old technology. This was the case for a US manufacturer of innovative X-Ray imaging equipment which had been denied approval for their innovative portable X-Ray device because its cutting edge features were actually prohibited by the current Chinese National Standard.
Brandwood Biomedical worked with the Chinese Test centre to define an overseas clinical data package which would provide the necessary assurances of safety and performance to allow the Test Centre to exempt the device from the “old Tech” clauses of the standard. The Test Centre report was accepted by CFDA and approval followed a short time later.
Got a ground breaking product which challenges the status quo? It may be necessary to negotiate an exemption to part or all of a technical standard. Our team includes technical experts on software, biocompatibilty, electrical safety, biological origin materials and more. We are active particpants in the standards writing process, with decades of experience of participation in ISO and national standards writing. We understand how standards work and are skilled in their interpretation and application.
Contact us to discuss your needs and for a free, no obligation appraisal. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)