Herre de Jong
Throughout my professional career of over 20 years in the medical device industry I bring a broad experience regarding quality management systems and conformity assessment processes. It’s my philosophy to establish simple and logical quality management systems that are clear at point of use and minimize device and regulatory risks, improve organizational performance and reduce time to market.
My experience comes from working in Quality Assurance and Regulatory Affairs at: Multiple medical device manufacturers, active and non-active, in Quality Assurance and Regulatory Affairs; and The notified body in CE certification of medical devices.
With my knowledge, I can help with all elements of:
– Quality Management Systems (CFR820, ISO13485, ISO 9001)
– Risk Management (ISO 14971)
– Regulatory requirements for Medical Devices (EU MDD, Canadian MDR)
And provide consulting services for:
– Establishing and maintaining quality management systems;
– Establishing, reviewing and maintaining technical documentation;
– Performing (gap) assessments
– Interfacing with authorities and notified bodies
– Providing training and performing auditing; and
– Related organizational aspects, including management in QA and RA.
Use one or more of the skills I have regarding:
– Establishing quality and regulatory mission, vision, strategies and organization(s);
– Leading Quality and Regulatory organization(s);
– Translating regulations and standards into quality management system requirements;
– Establishing risk based quality management systems processes that sustainably meet regulatory requirements;
– Establishing change in quality management system(s) or elements thereof that work for an organization;
– Establishing design controls, purchasing controls, production controls, process validation, change controls, CAPA processes, non-conformance processes, complaint handling, software validation etc.;
– Aligning quality management systems with regulatory submission requirements;
– Balancing competence and required documented ways of working;
– Auditing – internal and external and preparation for regulatory inspections and audits.