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 also provides highly respected European Authorized Representative services for non-European manufacturers.
Donawa consultants can assist with issues related to both the CE marking of new devices to the European regulations (MDR, 2017/745 and IVDR, 2017/746) as well as supporting manufacturers who are in the process of transitioning their devices to MDR/IVDR compliance.
For the US market, Donawa 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
Donawa 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. Donawa is also experienced in attending during FDA client inspections, to assist with interpretational issues, should they arise.
Donawa 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
Donawa 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. Donawa can help companies understand these differences, so that project milestones can be more efficiently reached within planned timelines.
Donawa 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.
Donawa 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.