Your partner in meeting the ever-evolving regulatory and quality system requirements in Europe and the United States
For over 25 years, a recognized resource for reliable and accurate US and European medical technology regulatory expertise, including active and non-active medical devices, in vitro diagnostics (IVDs), combination products and ATMPs. Donawa Lifescience Consulting (DLC) also provides highly respected European Authorized Representative services for non-European manufacturers.
DLC consultants can assist with issues related to both the current device directives and the new medical device regulations that are now in effect and which become mandatory in May 2020 for medical devices and May 2022 for IVDs, offering support for CE marking technical documentation and design dossiers.
For the US market, DLC offers support for pre-market submissions to the US Food and Drug Administration (FDA), including for Pre-Subs, 510(k)s, de novos, PMAs, and more.
EU and US quality system services
DLC is well known in the area of US and European quality management systems compliance, conducting on-site gap analyses and quality audits for compliance to European and US requirements, helping clients prepare for Notified Body / ISO 13485 audits and FDA inspections, and providing advice on corrective action where needed. DLC is also experienced in attending during FDA client inspections, to assist with interpretational issues, should they arise.
DLC can also help companies develop a compliant quality system from scratch, including requirements for post-market surveillance, complaints, and field safety activities, to meet both European and US requirements and expectations.
Combination product services
DLC can help you formulate effective European and US regulatory and quality system strategies for the device components of combination products, and if requested, provide feedback and support regarding the drug component.
Important differences exist in the US and European regulation of drug-device combination products and drug delivery devices. DLC can help companies understand these differences, so that project milestones can be more efficiently reached within planned timelines.
DLC can provide the support needed to understand and properly interpret US regulatory, quality system and clinical data requirements for combination products, including interpretation of "grey" areas and anticipation of FDA expectations, which are fundamental for the success of the regulatory process for combination products destined for the US.
DLC has the knowledge and experience to assist you in the development of effective medical device, IVD and combination product regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.