Quality management systems
Build, implement and improve a practical QMS aligned with ISO 13485. Support for procedures, CAPAs, supplier controls, audits and continuous improvement.
Independent QA/RA support
Make medical innovation ready for the real world.
Practical regulatory affairs and quality assurance for medical device teams. From building a quality system to navigating EU MDR and US FDA requirements, with a special focus on software as a medical device.
Clear. Compliant. Confident.Quality and regulation, made practical.
Experience across the medical technology lifecycle
EU MDR
FDA 510(k)
ISO 13485
ISO 14971
SaMD & AI
ISO 27001
NEN 7510
PRRC
How I can help
Expertise that moves your product forward.
Whether you're establishing the foundations or preparing for the next regulatory milestone, get experienced support that fits your team and your stage of growth.
Regulatory strategy & submissions
Navigate EU MDR and US FDA pathways, including technical documentation, CE marking support, FDA 510(k) clearances and regulatory interactions.
Software, AI & digital health
QA/RA support tailored to software as a medical device, AI-enabled products, software lifecycle processes and the connection between quality and information security.
Information Security Management System (ISMS)
Setting up and maintaining an Information Security Management System in line with ISO 27001 and NEN 7510 requirements. Practical support covering risk assessments, controls, policies and certification readiness for medical device and digital health organisations.
Audits
Planning and performing internal audits of quality management systems and information security management systems based on ISO 13485 and ISO 27001. Supplier audits and audit preparation support to help your organisation stay compliant and inspection-ready.
A pragmatic approach
Good compliance should enable progress.
Regulatory and quality work is most useful when it is clear, proportionate and embedded in the way your team already works.
01
Understand your product and priorities
Start with your technology, intended use, development stage and business goals to focus effort where it matters most.
02
Build a clear, workable plan
Identify the gaps, key risks and regulatory deliverables, then agree on practical next steps with your team.
03
Work alongside your team
Hands-on support for documentation, systems and regulatory activities, with knowledge transfer so the solution lasts beyond the project.
Thoughtful quality. Confident regulatory decisions.
About Sparkmed
Experienced support, without unnecessary complexity.
Sparkmed is run by David Sparks, a Quality Assurance and Regulatory Affairs professional with experience across medical technology startups and digital health.
David's experience includes setting up and maintaining quality management systems, supporting EU MDR compliance, preparing technical documentation, and working toward CE marking and FDA clearance. Sparkmed brings a particular understanding of software-based medical devices, including AI-enabled medical imaging and digital health applications.
Fluent Dutch & English
Startup experience
Medical software & AI
Relevant experience
Built through hands-on work in med-tech.
Experience spanning a range of hardware and software-based med-tech start-up and scale-up companies — across both quality systems and regulatory submissions.
Ask about my experience ↗David has gained broad QA/RA experience across a range of hardware and software-based med-tech start-up and scale-up companies. This includes working in digital health, non-invasive monitoring sensors, AI-based medical imaging software and medical device software tools.
Throughout these engagements, responsibilities include building and maintaining quality management systems, achieving and maintaining CE MDR and FDA clearances, producing technical documentation, managing supplier controls, and supporting information security management, as well as performing internal audits, supplier audits, and engaging directly with notified bodies and regulatory authorities.
This hands-on experience across multiple organisations and product types gives Sparkmed a practical, grounded perspective on what it takes to bring a medical device to market and keep it compliant.
Let's connect
Have a product to move forward?
Tell me where you are in your development or compliance journey. We can discuss what support would be most useful for your team.
Start a conversation ↗
Email
david@sparkmed.nl
Based in
Utrecht, The Netherlands