Quality Systems

DLC is a recognized leader in US and European quality system development, implementation, assessment and compliance. Equally proficient with ISO 13485, 21 CFR 820 and PAL 169 quality systems.

Software Compliance

Compliance of medical device software with US and European regulatory requirements needs very specific expertise, which DLC has available to assist companies, from early development to market clearance.

Environmental Services

A new service for device companies, provided by our experienced Environmental Affairs Associate, helping companies meet the growing list of European environmental directives and standards.

Clinical Studies in Europe

Located throughout Europe, a full-service European CRO specializing in medical devices and conducting clinical studies that are valid for the US and elsewhere. Visit our dedicated CRO website further details.

The DLC Quality, Regulatory and Clinical Study services are managed from our headquarters in the historical centre of Rome, Italy. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.