ISO Certification Made Easy for Healthcare Start-ups & Scale ups

I am Craig Ladley, a specialist in Quality, Continuous Improvement, and Operations with over 20 years of experience across various industries, including technology and healthcare. I founded CJ & L Consultancy Ltd in 2021 to better assist start-ups and scaling businesses in structuring their operations. My consulting journey includes support for a healthcare start-up focused on complex lung and heart diseases, where I contributed to implementing ISO13485 standards and played a key role in raising £6.5 million during an A-round funding campaign. After ending my tenure with the start-up in November 2024, I relaunched my consultancy, forming partnerships with companies like Cognidox and Cambridge Networks, and leveraging insights from industry consultants to expand my network and drive innovation in operational excellence.

Key Projects:

• Stabilized the fractured quality system based on critical BSI findings with ISO13485 and MDR 2017/245 and EU MDR.
• Provided a gap analysis to ensure the quality system and products met regulatory and compliance standards of ISO13485, MDR, MDSAP and 21 CFR within the business.
• Provided training and guidance to team leaders to ensure new medical devices were developed as required by ISO14971 (Risk Management) prior to reaching the market.
• Lead clients to gain ISO13485 certification with 2 x Clients, both SaMD and re-certification audits with 1 x Client, that are class 2A and B
• Built and created full SaMD using Apps with University from scale up to release.
• Lead a client to gain ISO27001 certification, by implementing all mandatory documents and full ISMS software.
• Lead client projects to implement a EQMS with up to 100 employees.
• Completed full auditing cycles in readiness for stage 1 and 2 audits
• Full introduction of the UDI labelling process for a clients with class 1 devices.
• Leading clients to complete and create Medical Device files from Design concept to manufacture, including guidance with clinical trials.
• Led transition from a university project to spin out into a running commercial entity towards UK & EU GDPR and Cyber Essentials Basic certification.