Medical Device EU/US Quality and Regulatory Services
Your partner from successful product launch to reaching your business objectives and beyond
US and European Device Regulatory
For over 20 years, a recognized resource for reliable and accurate US and European medical technology regulatory expertise, including combination products and ATMPs. Donawa Lifescience Consulting (DLC) also provides highly respected European Authorized Representative services.
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.
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.
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 and IVD Performance Studies in Europe, US and Canada
We are a full-service CRO specializing in medical devices, IVDs and combination products, managing and monitoring clinical studies that are valid for the US and elsewhere. Visit our dedicated CRO website for 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.