CJ & L Consultancy Ltd
At CJ & L Consultancy Ltd, we empower businesses with expert support across Quality Management, Regulatory Compliance, Information and Cyber Security compliance. With deep experience in ISO standards (9001, 13485, 27001,), EU/UK medical device regulations, Lean transformation, and technical documentation, we help startups and established organizations achieve certifications, and scale with confidence. Whether you need a new QMS, medical device compliance, or implementation of an ISMS or Cyber security, we deliver practical, results-driven solutions tailored to your needs.
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.
At CJ & L Consultancy Ltd, our mission is to empower organizations—whether startups or established enterprises—by delivering tailored, practical, and sustainable solutions in quality management, operational excellence, and regulatory compliance. With over two decades of cross-industry experience, we help our clients navigate complex challenges, build robust frameworks, and unlock long-term value through integrity, innovation, and a relentless focus on improvement.
Products and services
Rent an eQMS – Your Ready-to-Use Compliance Solution
CJ & L Consultancy now offers start ups and small businesses with up to 10 employees the opportunity to include a multifunctional Electronic Quality Management System (eQMS), designed to align with leading compliance standards including ISO 9001, ISO 13485, ISO 27001, and ISO 45001.
Fully adaptable and tailored to your organisation, our eQMS is immediately available, giving you the tools you need to stay compliant and efficient from day one.
Why choose our eQMS?
- Ensures alignment with quality, regulatory, and safety requirements.
- Saves significant time on documentation, training, and change control.
- Provides a cost-effective alternative to expensive in-house systems.
- Ensures audits are compliant and relieves stress.
- Fully managed service available, so you can focus on growth.
What’s included:
- Key expert to act as your companies Person Responsible For Regulatory Compliance (PRRC), and act as your Quality Manager
- Pre-populated eQMS modules specific to your chosen ISO standard(s).
- Secure hosting on ISO27001 certified servers.
- Tailored procedures, templates, and workflows adapted to your needs.
- Full access to modules including training, change management, and more.
- User training to help your team get the most from the system.
Additional support includes:
- End-to-end delivery of your full internal audit programme in line with your ISO requirements.
- Dedicated guidance across all compliance activities for your chosen ISO standard, right through to Stage 1 and Stage 2 certification or notification body audits.
- Full support to adapt and align all provided templates with your existing procedures and ways of working.
- Development and maintenance of new or existing Technical Files for your medical device — including Software as a Medical Device (SaMD).
Interested in understanding more, please book a demo using the button below
One-time UK GDPR Compliance Audit.
This new service includes a comprehensive UK GDPR checklist based on:
UK regulatory requirements
ICO guidance
Cyber Essentials standards
ISO 45001 (Occupational Health) Implementation Service
we’re proud to offer a comprehensive ISO 45001 Occupational Health & Safety Management System (OHSMS) implementation service, guiding your organization through every step—from documentation to successful certification.
Our End-to-End Implementation Approach Includes:
1. Initial Gap Analysis & Planning
We begin with a structured gap analysis to assess your current health and safety practices against ISO 45001 requirements. This includes reviewing existing documentation, processes, risk controls, and legal compliance. From this, we develop a tailored implementation roadmap with clear milestones and responsibilities.
2. System Design & Documentation
We design a customized ISO 45001-compliant OHSMS, including:
- Health & Safety Policy and Objectives
- Roles, Responsibilities & Authorities
- Hazard Identification & Risk Assessment Framework
- Operational Controls and Emergency Preparedness
- Legal & Regulatory Compliance Registers
- Worker Participation Mechanisms
- Monitoring, Measurement, and Incident Reporting Procedures
- Internal Audit and Management Review Templates
All documentation is written in plain language, aligned with your operational context, and developed collaboratively to ensure ownership and usability across your organization.
3. Training & Awareness
We provide targeted training sessions for leadership, safety representatives, and staff. This includes:
- ISO 45001 awareness
- Roles in the OHSMS
- Incident reporting and investigation
- Legal obligations and employee rights
We promote a culture of safety and engagement, encouraging participation and proactive risk management.
4. Implementation Support
We guide your team through the practical application of the system. This includes:
- Embedding procedures into daily operations
- Supporting hazard reporting and investigation processes
- Coaching internal auditors
- Advising on corrective and preventive actions
- Integrating health & safety into strategic planning
5. Internal Audits & Management Review
We conduct or support internal audits to verify system effectiveness and compliance. We help prepare for and conduct Management Reviews, ensuring top-level engagement and continual improvement.
6. Certification Audit Readiness
We assist in selecting an accredited certification body and prepare your organization for the external audit through:
- Final system checks and documentation review
- Mock audits and audit coaching
- Attending and supporting you during Stage 1 and Stage 2 audits
- Advising on any non-conformance resolution
Information Security Management System (ISMS)
- Offering comprehensive support and guidance in achieving ISO27001 certification with your selected certification or notified body.
Additionally, we offer assistance in conducting internal audits and delivering gap analysis or opportunities for improvement.
Business Improvement Support
- Gap assessments
- Simulated inspections
- Staff training and development
- Support before and after inspections
- Process improvement initiatives
- Technical Good Manufacturing Practices Quality Assurance assistance – intricate investigations, technology transfers
Regulatory Compliance Guidance
- Determining the classification of devices and the relevant regulatory requirements.
- Creating a regulatory strategy to launch the product in the selected country or countries and region or regions.
- Preparing for and facilitating inspections by Regulatory Authorities, while also managing remediation efforts.
Quality Management System
- Projects focused on the design, implementation, and improvement of Quality Management Systems (QMS)
- Services for writing and reviewing policies and Standard Operating Procedures (SOPs)
- Drafting and reviewing technical agreements
