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CRO Services
Clinical Study Submissions
Regulatory and Quality
Clinical Evaluation

For over 20 years...

A leading European CRO, Regulatory & Quality System consultancy for medical devices, IVDs and drug-device combination products operating in the EU and US.


CRO Services
 

CRO Services

Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products.
Clinical Study Submissions
 

Clinical Study Submissions

High quality submissions to European and US regulatory authorities, plus negotiation of site agreements for medical device and IVD studies.
Regulatory and Quality
 

Regulatory & Quality

Expert assistance with any EU or US related regulatory or quality system issue for all types of medical device, including IVDs and combination products.

Clinical Evaluation
 

Clinical Evaluation

Extensive experience in developing high quality clinical evaluation reports and assistance with equivalence determination and device clinical data strategy.


Global News

Donawa Lifescience Consulting announces opening of CRO Office in United States
25 October 2019
Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients.
 
Donawa Lifescience Inc., together with DLC in Rome, are available to assist clients with clinical studies in the US, Canada and Europe. The newly appointed Director US Operations is Ana-Maria Panaitoiu, M.D., a physician with more than 20 years’ experience with drug, medical device and IVD investigational studies in multiple therapeutic areas in the US and Canada.
 
With the forthcoming transition to the European Medical Devices Regulation (MDR, 2017/745), even existing CE marked devices may require clinical studies to confirm their safety and clinical performance, with the need for Post-Market Clinical Follow-up (PMCF) studies expected to increase significantly.
 
DLC, working closely with Donawa Lifescience Inc., is particularly well-placed to help clients negotiate the clinical study and PMCF requirements of the MDR, and also assist with updating existing Clinical Evaluation Reports to meet increased Notified Body scrutiny and expectations.
 
The DLI office is located at 245 First St, Cambridge, Massachusetts 02142, and contact details are:
 
Ana Maria Panaitoiu, M.D., Director US Operations
Email: apanaitoiu@donawa.com
Tel: +1 514 824 9101
FDA publishes its list of guidance priorities for 2020
15 October 2019

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published a list of the guidance documents that it considers to be of the highest priority for development and publication in 2020.

The list, available from here, includes:

  • The A-list: A list of prioritized device guidance documents that the Agency intends to publish during FY2020, and
  • The B-list: A list of device guidance documents that the Agency intends to publish as resources permit during FY2020.

Also included, for interest, are copies of the lists of final guidance documents issued in 1980, 1990, 2000, and 2010.

CDRH is seeking public comment on the A and B lists.

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