Product Definition
Well defined product concepts with clear intended uses and indications are key to proper classification under the European Union Medical Device Directives. DDD has helped companies with product definition and in negotiating device classifications. Its consultants have assisted in creating the needed risk analysis and hazard mitigation documents.
Test Plans & Standards Compliance
In collaboration with our clients, DDD develops plans for design verification testing and assists clients with standards compliance. DDD has experience overseeing biocompatibility, electromagnetic compatibility, eletrical product safety, electro-static discharge and toxicity testing.
Technical Dossiers
DDD has helped its clients develop and maintain the requisite technical product dossiers.
CE Marking
DDD has assisted companies in achieving ISO quality system certifications as a basis for CE marking of medical and laboratory products. Translations of instructions for use, development of multi-lingual training programs, selection of authorized representatives are examples of roles played by DDD in CE marking for placing products on the European market.