Over the past year, my consultancy journey in the medical device sector — supporting both SaMD and hardware innovators — has accelerated in ways I’m incredibly proud of. What began as a focused offering has now grown into a multi‑disciplinary, high‑value service model that reflects the evolving needs of start‑ups and scale‑ups across the industry.
Building on Strong Foundations
Since my last update, the pace has been intense. I’ve had the opportunity to form new, meaningful consultancy partnerships and expand my subject‑matter expertise into adjacent but critical domains, including:
- Cyber Security implementation
- DST and NHS Digital Toolkits
- ISO 27001 readiness and certification support
These additions mean clients can now rely on me not only for medical device compliance but also for the broader digital, security, and operational frameworks that modern MedTech companies must master.
A Full-Service Expert Network
One of the most exciting developments has been the creation of a wider expert ecosystem. I can now offer clients access to a coordinated team covering:
- Quality & Regulatory
- Health Economics
- IEC 62304 Design & Development
- Cyber Security & ISMS
- eQMS and ISMS platform selection and optimisation
This integrated model allows clients to run complex projects through one consultancy, rather than sourcing multiple specialists. It reduces friction, increases efficiency, and ensures consistent quality across every stage of development.
Rising Demand & Expanding Capabilities
Project enquiries have increased significantly — not only for SaMD and medical device compliance, but also for Cyber Essentials, NHS Digital Toolkits, DST, and especially ISO 27001. Much of this growth has come through word of mouth, which is the strongest validation of the value delivered so far.
A Strategic Move: New Office, New Opportunities
A major operational milestone is now underway. To improve efficiency, expand services, and create a better balance between work and home life, I’m moving into a new office at a local business park on 1st October.
This move brings several advantages:
- A larger footprint to grow the consultancy
- On‑site parking
- Reduced daily travel time (saving around 1 hour 30 minutes per day)
- Proximity to businesses that benefit from expert MedTech guidance
- Full visibility and branding opportunities
My eldest son is particularly pleased — he gets more quiet time at my new office, and not at home!
New Services: Hosting Audits & QMS Operations
With the new office, I will be expanding services further. CJ&L Consultancy Ltd will soon be able to host:
- ISO 9001
- ISO 13485
- ISO 27001
- MDR compliance activities
- Stage 1 & 2 audits
- Unannounced audits
- Full QMS operational support
This gives start‑ups and scale‑ups a cost‑effective alternative to renting their own office space, while ensuring they have a dedicated, compliant environment for their quality and regulatory needs.
If you’d like to explore how CJ&L Consultancy Ltd can support your next project — whether you’re building a SaMD, scaling your QMS, or preparing for certification — feel free to reach out:
Email: [email protected]
Direct Number: 01284 663831