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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

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.

Full Service European CRO

Located throughout Europe, a full-service European CRO specializing in medical devices and conducting clinical studies that are valid for the US and elsewhere.

 

Quality Systems

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

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Public consultation launched on recast of EU device directives. Click here.
FDA to recruit 1,300 scientists. Click here.
FDA approves new type of latex glove. Click here.

Revised Medical Device Act now in effect in Thailand. Click here.

Appointment of FDA Deputy Commissioner announced. Click here.
Public consultation launched on recast of EU device directives. Click here.
 
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