Why CE Mark Express?

• An enviable track record of getting it right the first time, every time!
• Product experience spanning disposable medical devices, in vitro diagnostic tests, artificial organs and cardiovascular implants.
• Accredited Consultants and Auditors providing proven materials, examples, and solutions that work.
• Experience gained from 4000+ product verifications, Registration and Surveillance Audits, with no major non-conformances.
• Experience gained from 200+ clients on CE Marking, CMDCAS, FDA, and Quality System Registrations.
• Benefit from CE Mark Express' professional associations, memberships, worldwide contacts, training, and education.
• World-renowned expertise in European Union, USFDA, Canadian, and Asian regulatory issues.
• High quality scientific expertise in: FDA product review, Clinical Trials, protocol development, current Good Laboratory Practices, current Good Manufacturing Practices, drug/device combinations, leading the introduction of new technology, and upscaling products from design to full manufacturing for a wide range of medical devices.
• Top notch Project Management expertise.
• Qualified professionals including Accredited Medical Devices Lead Auditor for various regulatory agencies and notified bodies, as well as Master’s and Doctorate level degrees from leading educational institutions.
• Established strategic partnerships and working relationships on every major continent and with every major regulatory agency.
• Additional key relationships with leading Notified Bodies, Testing Laboratories, Quality System Registrars, and Medical Institutions worldwide. This strong network of expertise allows us to provide our clients with the most current and leading edge interpretations of directives, standards, and regulations, ensuring your product testing is always appropriate, cost-effective, and up-to-date!
• Qualified worldwide services to meet global needs, as well as the provision of quality local solutions that meet specific organizational needs.
• Seminar leaders who have presented at such industry-recognized events as Biotechnica America 2003 in Monterey (California), Pharmaceutical/ Biopharmaceutical and Medical Devices in Asia, Asia BioMed - Singapore, and QualCon 2003 - Australia.
• Leaders in industry-related research on such topics as: Standards, Quality Systems, and Product Certification as part of the Federal Regulatory Process, National and International Standards Systems, Value and Market Access Through Effective Conformity Assessment, and Using Quality Systems to Your Advantage, and collaboration on 100+ National Standards of Canada, and International ISO and IEC Standards on medical devices and biotechnology.
  

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Receiving a CE Mark will open medical device regulatory doors right around the world!