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Medical devices have changed over the centuries and so have device regulatory requirements. We can help you meet these continually evolving needs

Donawa Consulting 
Your partner from successful product launch to reaching your business objectives and beyond

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.

US and European Device Regulatory

For over 20 years, a recognized resource for reliable and accurate US and European medical technology regulatory expertise, also providing highly respected European Authorized Representative services.


US and European Pharmaceutical Regulatory

With extensive experience in drug product requirements, providing tailored assistance to pharmaceutical companies wishing to meet European or US regulations, including those for combination products and ATMPs.

Quality Systems
Recognized leader in US and European quality system development, implementation, assessment and compliance.

 

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


 

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Italian device registration deadline extended again. Click here.

Industry requests REACH exemption for DEHP in devices. Click here.

GHTF issues two draft guidance documents. Click here.

MHRA issues vigilance guidance for IVC filters. Click here.

Australia’s TGA introduces IVD regulations. Click here.

Italian device registration deadline extended again. Click here.

 


Medical Device CEO Clinical Primer
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