About me
I am Craig Ladley a Quality and Business Improvement professional and founder of CJ & L Consultancy Ltd where i support startups, scaling ventures, and large private and public companies. With over 20 years of experience, I specialize in creating robust frameworks for operational excellence and quality. My skill spans industries in Healthcare, Pharmaceuticals, Aerospace, Medical Devices, and Artificial Intelligence. I leverage our skill to help businesses in implementing quality management systems. These systems align with ISO standards like ISO9001, ISO13485, ISO14001, and PS9000. Additionally, I offer operational excellence support to help reduce costs and time inefficiencies within your operations. Additionally, we offer comprehensive support to guarantee compliance with relevant medical regulations. This applies whether your device is software as a medical device or hardware. We help you meet the legislation requirements in your target market. I offer guidance to stakeholders on corrective measures and make sure compliance with evolving standards and regulations. I work collaboratively with C-Suite executives and develop strategies that align with key commercial goals and objectives.
Notable projects I have led include implementing a project management system. Another is an Electronic Quality Management System. Whilst achieving ISO13485 certification for a startup company.
Industry
Skills
Compliance Supervision and Audits Total Quality Management (TQM) Information security management Continual improvement
Work history
Jan 2020 - Present
Achievements
ISO13485 certification
Qureight Ltd , 2022
Gained certification of ISO13485 with a SaMD with no NC's at either stage 1 or stage 2 audits.
Investment A round
Qureight Ltd , 2024
Successfully achieved significant investment funds for the company to drive the business forward.
EQMS
Qureight Ltd, 2022
Introduced an EQMS into the business to effectively manage all medical device files and quality management documentation.