Username

Password

Forgot Password?

Preview

Sign-in free and Explore the Exciting World of BiomedExperts:

Over 1.500.000 Profiles
More than 1.800 Organizations worldwide
State of the Art Network Visualizations

Manage your own Profile
Locate Experts in your Country/Region
Locate Experts in your 1. and 2. Level Network
Connect to Experts Worldwide

NetworkView

Maria Donawa

This is a preview profile on BiomedExperts - the first literature-based scientific social network. It brings the right researchers together and allows them to collaborate online. Collexis and Dell provide the BiomedExperts network of +1.5 Million pre-calculated profiles free of charge to researchers worldwide.

Research Profile (preview)

Devices

Equipment and Supplies

Activities & Behaviors

Concepts & Ideas

Geographic Areas

Organizations

Procedures

Sign-in to see full Profile

Network (preview)

Co-Publications
Name

Sign-in to see all Coauthors

Publications

TOP 3
Donawa Maria
Meeting US and European supplier control requirements.
Donawa Maria
Avoiding surprises when implementing a single quality system.
Donawa Maria
Addressing Eeuropean environmental legislation.

Sign-in to see all Publications

Sign in free and see...

Visualized networks:

See your personal network in
sophisticated graphical views

GeoTargeted Searches:

Locate experts around the world
and connect with global collaborators

Research Profiles:

See the visualized research activity
of experts around the globe

Sign-in to see more

Geonetwork of Maria Donawa (preview)

Cities where this author has publications
Cities where co-authors of this author have publications

Flash Player Required

Sign-in to see more

All Publications

2009: Donawa Maria
Meeting US and European supplier control requirements.
Medical device technology 2009;20(3):24-7.
2009: Donawa Maria
Avoiding surprises when implementing a single quality system.
Medical device technology 2009;20(2):28, 30-1.
2009: Donawa Maria
Addressing Eeuropean environmental legislation.
Medical device technology 2009;20(1):20, 22-3.
2008: Donawa Maria E
The evolving process of European combination product review, Part I.
Medical device technology 2008;19(6):32, 34-5.
2008: Donawa Maria
Addressing US and European device testing requirements.
Medical device technology 2008;19(5):32, 34-7.
2008: Donawa Maria
New Italian device registration requirements.
Medical device technology 2008;19(3):26, 28-9, 31.
2008: Donawa Maria E
Who owns the 510(k)?
Medical device technology 2008;19(2):26, 28-9.
2008: Donawa Maria
Scope of the European Medical Device Directives.
Medical device technology 2008;19(1):32, 34-5.
2007: Donawa Maria
Implementing new European vigilance procedures.
Medical device technology 2007;18(7):34, 36-7.
2007: Donawa Maria
Auditing device clinical studies for US requirements.
Medical device technology 2007;18(6):24-7.
2007: Donawa Maria
Competent authority conference on medical devices.
Medical device technology 2007;18(5):28-31.
2007: Donawa Maria
Complying with US nonconforming product requirements.
Medical device technology 2007;18(3):22, 24-5.
2007: Donawa Maria
Risk management of European device clinical studies.
Medical device technology 2007;18(2):39-42.
2007: Donawa Maria
Insurance coverage for European device clinical studies.
Medical device technology 2007;18(1):38-41.
2006: Donawa Maria
New efforts to harmonise clinical evaluation.
Medical device technology 2006;17(9):28, 30, 32.
2006: Donawa Maria
Managing clinical data for worldwide acceptance.
Medical device technology 2006;17(8):26-8.
2006: Donawa Maria
Strategic planning for U.S. premarket approval submissions.
Medical device technology 2006;17(7):21-3.
2006: Donawa Maria
Effectively incorporating risk management into quality systems.
Medical device technology 2006;17(5):28-30.
2006: Donawa Maria
US regulation of Advertising and promotional materials.
Medical device technology 2006;17(4):26-8.
2006: Donawa Maria
Organising European technical documentation to avoid duplication.
Medical device technology 2006;17(3):29-31.
2006: Donawa Maria
US guidance on formatting 510(k)s.
Medical device technology 2006;17(2):27-9.
2006: Donawa Maria
Proposed amendments to the medical devices Directives.
Medical device technology 2006;17(1):22-5.
2005: Donawa Maria
Useful US guidance on device software.
Medical device technology 2005;16(10):18-20.
2005: Donawa Maria
European requirements for product returns.
Medical device technology 2005;16(9):28-31.
2005: Donawa Maria
Conducting clinical studies in Italy.
Medical device technology 2005;16(8):21-4.
2005: Donawa Maria
Understanding US labelling requirements.
Medical device technology 2005;16(7):21-3.
2005: Donawa Maria
US importer and distributor requirements.
Medical device technology 2005;16(5):25-7.
2005: Donawa Maria
Preparing for more active market surveillance.
Medical device technology 2005;16(4):30-3.
2005: Donawa Maria
U.S. medical device reporting: who is responsible?
Medical device technology 2005;16(3):27-9.
2005: Donawa Maria
US and European postmarket clinical data requirements.
Medical device technology 2005;16(2):19-21.
2005: Donawa Maria E;
FDA draft guidance on computerised systems used in clinical trials.
Medical device technology 2005;16(1):24-7.
2004: Donawa Maria
European medical device regulation: a new era?
Medical device technology 2004;15(10):30-1.
2004: Donawa Maria
The US medical device bundling policy.
Medical device technology 2004;15(9):25-7.
2004: Donawa Maria
Successful recruitment for medical device clinical studies.
Medical device technology 2004;15(8):25-7.
2004: Donawa Maria E
The essential element of ethics.
Medical device technology 2004;15(5):27-9.
2004: Donawa Maria
Effective risk management programmes.
Medical device technology 2004;15(4):28-30.
2004: Donawa Maria
Beyond the US submisson process.
Medical device technology 2004;15(3):30-2.
2004: Donawa Maria E
Guidance on submitting quality system information.
Medical device technology 2004;15(2):24-7.
2004: Donawa Maria
European Animal Tissue Directive.
Medical device technology 2004;15(1):28-31.
2003: Donawa Maria
Getting it right in Europe.
Medical device technology 2003;14(10):34-6.
2003: Donawa Maria E
FDA pilot programme in support of global harmonisation.
Medical device technology 2003;14(9):32-4.
2003: Donawa Maria
Managing changes during a clinical investigation, Part II.
Medical device technology 2003;14(8):24-7.
2003: Donawa Maria
Managing changes during a clinical investigation, Part I.
Medical device technology 2003;14(7):31-3.
2003: Donawa Maria
Avoiding rejections by European ethics committees.
Medical device technology 2003;14(5):26-8.
2003: Donawa Maria E
IVD authorized representatives.
Medical device technology 2003;14(4):19-21.
2003: Donawa Maria
Change in FDA stance on Part 11 Requirements.
Medical device technology 2003;14(3):24-6.
2003: Donawa Maria
Review of the Medical Device Directive.
Medical device technology 2003;14(2):20-3.
2003: Donawa Maria
The dilemma of reporting device-related adverse events.
Medical device technology 2003;14(1):26-31.
2002: Donawa Maria
FDA user fee and Modernisation Act.
Medical device technology 2002;13(10):27-9.
2002: Donawa Maria
Adverse event management during clinical investigations.
Medical device technology 2002;13(9):36-40.
2002: Donawa Maria
The new FDA combination products programme.
Medical device technology 2002;13(8):25-8.
2002: Donawa Maria
Update on the forthcoming European Clinical Investigation Standards.
Medical device technology 2002;13(7):24-5.
2002: Donawa Maria E
Implementation of the medical device directives in Italy.
Medical device technology 2002;13(5):26-8.
2002: Donawa Maria E
The IVD directive: planning for compliance.
Medical device technology 2002;13(4):22-4.
2002: Donawa Maria
FDA final guidance on software validation.
Medical device technology 2002;13(3):20-4.
2002: Donawa Maria
Update on ISO 13485.
Medical device technology 2002;13(2):23-5.
2002: Donawa Maria
New US agent requirements.
Medical device technology 2002;13(1):35-7.
2001: Donawa M
The Center for Devices and Radiological health: an update.
Medical device technology 2001;12(10):24, 26-7.
2001: Donawa M
New FDA guidance on electronic records and signatures.
Medical device technology 2001;12(9):32-5.
2001: Donawa M
Update on the European database.
Medical device technology 2001;12(8):21-4.
2001: Donawa M
An important step forward in the global harmonisation of premarket review programmes.
Medical device technology 2001;12(7):28-30.
2001: Donawa M
US inspections of clinical investigation sites.
Medical device technology 2001;12(5):25-8.
2001: Donawa M
New guidance on the European declaration of conformity.
Medical device technology 2001;12(4):21-4.
2001: Donawa M
Final FDA inspection manual.
Medical device technology 2001;12(3):29-32.
2000: Donawa M
Another design input: reimbursement issues.
Medical device technology 2000;11(10):32-4, 37.
2000: Donawa M
Notified body recommendations.
Medical device technology 2000;11(4):37-40.

Sign-in to see more