Based in Scotland (UK), iDE8 supports digital health and medical device innovators across Europe to bring products to market — faster, safer, and fully compliant.
We specialise in quality assurance, regulatory strategy, and medical device development, working with both early-stage start-ups and established global leaders.
As a potential UNITE project partner, we bring hands-on expertise in:
CE-marking & EU/UK regulatory compliance (MDR, IVDR, ISO 13485)
End-to-end quality management systems (QMS) setup and audits
Device testing strategies and post-market surveillance
Process optimisation for remote care and data-driven solutions.
Regulatory navigation across cross-border EU markets
Our role in a consortium:
We help project partners de-risk innovation by ensuring their solutions meet the right regulatory pathways from concept to market. We also support capacity building through training and knowledge transfer.
“We turn bold digital health ideas into market-ready solutions — with quality and compliance built in.”
📍 _Region: Scotland (eligible UNITE region)
🔗_ https://www.medicaldeviceconsultancy.com/_
Open to joining consortia as a regulatory/QMS work package lead or expert advisor._
Area of activity
Additional questions
Which of the four UNITE Challenges does your organization tackle?
In which UNITE region are you located in?
Managing Director | Principal Consultant
iDE8
Product
Quality System Support for Medical Devices
ISO 13485 and QMS implementation, audits, CAPA, risk & process quality — built for device innovators scaling safely and compliantly.
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
Product
Software Quality Engineering for Medical Devices
Hands-on software quality support across IEC 62304, cybersecurity, testing, compliance audits, and lifecycle traceability.
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
Product
Regulatory Strategy for Software as a Medical Device (SaMD)
CE, UKCA, FDA pathways for digital health & SaMD including CERs, submissions, and lifecycle compliance.
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
Product
End-to-End Testing for Medical Devices & SaMD
Verification & validation, custom methods, test rig development, and execution under ISO 13485 QMS.
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
Product
Project Management for Medical Device Development
Specialised project leadership across hardware, software & regulatory deliverables to bring medical devices to market — on time, every time.
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom