4 employees
Consultant
Analyzed business operations and provided expert consultation on quality/compliance management as well as engineering and CE/UL regulations. CE Mark Application for Class I Medical Devices per the European Union's Medical Device Directive 93/42/EEC.
Worked with companies ranging in size from $1M to $30M; achieved 100% certification success rate in ISO 9001 Registration, ISO 13485:1996 Registration as well as unifying ISO 9001 and FDA cGMP into one quality system (for companies that wish to CE mark their medical devices).
Trained client staff in maintaining systems and conducting internal audits to ensure continued compliance.
Led project management/engineering of product testing/certification; enabled new market launches.